Setter: A FOIA Getter

Hello, _x000D_ _x000D_ Would it be possible to obtain a list of vapor (vape) product manufacturers currently operating in/from Arizona? I checked TRLM, but there were no resources there unfortunately. The data should include the manufacturer's name and address._x000D_ _x000D_ Thank you,_x000D_ Durim Berisha

Requester: Durim Berisha - Durim Berisha

Request for Approved Documents of (RLD # N006488) XYLOCAINE W/ EPINEPHRINE as mentioned below and refer (Attachment) for further details._x000D_ 1. CMC Documents, _x000D_ 2. Labeling packaging Documents, _x000D_ 3. Administrative Documents, _x000D_ 4. Clinical Pharmacology and Bio Pharmaceutics Review Documents_x000D_…

Requester: Dr. Rajender Singh - Mankind Pharma Ltd.

Gastrocrom® (cromolyn sodium, USP) Oral Concentrate 100 mg/ 5 mL, RLD (N020479) _x000D_ Request for Approved Documents as mentioned below. Refer (Attachment) for further details_x000D_ 1. CMC Documents, _x000D_ 2. Labeling packaging Documents, _x000D_ 3. Administrative Documents, _x000D_ 4. Clinical Pharmacology and …

Requester: Dr. Rajender Singh - Mankind Pharma Ltd.

Please provide the following inspection-related document in electronic PDF format: The 483 (in electronic format) for: FEI: 3003941038 Inspection date: 02/21/2025 Firm Name: Shouguang Fukang Pharmaceutical Co., Ltd. Country: China

Requester: Dr. Markus Felgenhauer - QYOBO GmbH

We are requesting case reports on the specified case numbers on toxicities/adverse effects associated with administration of Xofigo (radium Ra 223 dichloride). This request is via the Freedom of Information Act. The reason for the request is for academic purposes. As per our previous communication, we have divided our…

Requester: Dr. John Villano - University of Kentucky

_x000D_ June 9, 2025_x000D_ _x000D_ Favus Institutional Research LLC_x000D_ P.O. Box 8420_x000D_ Ann Arbor, MI 48107_x000D_ Elliot@FavusLLC.com_x000D_ Phone: (917) 952-8158_x000D_ _x000D_ Food and Drug Administration_x000D_ Division of Freedom of Information_x000D_ Office of the Executive Secretariat, OC _x000D_ 5630 …

Requester: Dr. Elliot Favus - Favus Institutional Research L

June 9, 2025_x000D_ Favus Institutional Research LLC_x000D_ P.O. Box 8420 Ann Arbor, MI 48107_x000D_ Elliot@FavusLLC.com_x000D_ Phone: (917) 952-8158_x000D_ Food and Drug Administration_x000D_ Division of Freedom of Information_x000D_ Office of the Executive Secretariat, OC_x000D_ 5630 Fishers Lane, Room 1035_x000D_ R…

Requester: Dr. Elliot Favus - Favus Institutional Research L

_x000D_ June 9, 2025_x000D_ _x000D_ Favus Institutional Research LLC_x000D_ P.O. Box 8420_x000D_ Ann Arbor, MI 48107_x000D_ Elliot@FavusLLC.com_x000D_ Phone: (917) 952-8158_x000D_ _x000D_ Food and Drug Administration_x000D_ Division of Freedom of Information_x000D_ Office of the Executive Secretariat, OC _x000D_ 5630 …

Requester: Dr. Elliot Favus - Favus Institutional Research L

_x000D_ June 9, 2025_x000D_ _x000D_ Favus Institutional Research LLC_x000D_ P.O. Box 8420_x000D_ Ann Arbor, MI 48107-8420_x000D_ Elliot@FavusLLC.com_x000D_ Phone: (917) 952-8158_x000D_ _x000D_ Food and Drug Administration_x000D_ Division of Freedom of Information_x000D_ Office of the Executive Secretariat, OC _x000D_ …

Requester: Dr. Elliot Favus - Favus Institutional Research L

_x000D_ June 9, 2025_x000D_ _x000D_ Favus Institutional Research LLC_x000D_ P.O. Box 8420_x000D_ Ann Arbor, MI 48107_x000D_ Elliot@FavusLLC.com_x000D_ Phone: (917) 952-8158_x000D_ _x000D_ Food and Drug Administration_x000D_ Division of Freedom of Information_x000D_ Office of the Executive Secretariat, OC _x000D_ 5630 …

Requester: Dr. Elliot Favus - Favus Institutional Research L

In accordance with Freedom of Information Act Procedures, Intertek Health Sciences Inc. requests any and all documents, as well as all internal and external CFSAN (including but not limited to the Division of Food Ingredients – Office of Food Additive Safety) communications pertaining to all submitted GRAS notices (…

Requester: Dr James Akingbasote - Intertek Health Sciences Inc.

In accordance with Freedom of Information Act Procedures, Intertek Health Sciences Inc. requests any and all documents, as well as all internal and external CFSAN (including but not limited to the Division of Food Ingredients – Office of Food Additive Safety) communications pertaining to all submitted GRAS notices (…

Requester: Dr James Akingbasote - Intertek Health Sciences Inc.

In accordance with Freedom of Information Act Procedures, Intertek Health Sciences Inc. requests any and all documents, as well as all internal and external CFSAN (including but not limited to the Division of Food Ingredients – Office of Food Additive Safety) communications pertaining to all submitted GRAS notices (…

Requester: Dr James Akingbasote - Intertek Health Sciences Inc.

In accordance with Freedom of Information Act Procedures, Intertek Health Sciences Inc. requests any and all documents, as well as all internal and external CFSAN (including but not limited to the Division of Food Ingredients – Office of Food Additive Safety) communications pertaining to all submitted GRAS notices (…

Requester: Dr James Akingbasote - Intertek Health Sciences Inc.

In accordance with Freedom of Information Act Procedures, Intertek Health Sciences Inc. requests any and all documents, as well as all internal and external CFSAN (including but not limited to the Division of Food Ingredients – Office of Food Additive Safety) communications pertaining to all submitted GRAS notices (…

Requester: Dr James Akingbasote - Intertek Health Sciences Inc.

Dear FDA FOIA Team, we need BE Assessment Report pertaining Our ANDA 216942

Requester: Dipti Kamani - Encube Ethicals Pvt Ltd

Dear FDA FOIA Team, we need BE Assessment Report pertaining Our ANDA 208620

Requester: Dipti Kamani - Encube Ethicals Pvt Ltd

1) How many investigations has the Office of Criminal Investigations initiated against drug manufacturing facilities located in India, during the timeframe specified (01/01/2010 - 06/06/2025) for the suspected crime of introducing adulterated drugs into interstate commerce? _x000D_ _x000D_ 2) Please provide a list of …

Requester: Dinesh Thakur - Dinesh Thakur

1. What regulatory action has the agency taken against Global Pharma FEI 3012323885 since it issued a warning letter MARCS-CMS 657325 dated October 20, 2023?_x000D_ _x000D_ 2. Can you please disclose whether the USFDA is contemplating criminal charges against Global Pharma FEI 3012323885 - the company's products have…

Requester: Dinesh Thakur - Dinesh Thakur

When were the following companies registered with the US FDA for the first time?_x000D_ 1) Astral SteriTech _x000D_ 2) Global Pharma _x000D_ 3) Klitch _x000D_ 4) MMC Healthcare _x000D_ 5) Brassica Pharma

Requester: Dinesh Thakur - Dinesh Thakur

Please provide all EIRs, Form 483s, warning letters, investigation memos, prosecution memos prepared with regard to Astral SteriTech Pvt. Ltd., whose registered address is 911 G I D C Makarpura, Vadodara, India & bearing FEI number: 3005508230

Requester: Dinesh Thakur - Dinesh Thakur

The applicant holder for Midazolam Hydrochloride Injection USP, 1 mg/mL and 5 mg/mL ANDA # 075494 application is Rising Pharma Holdings Inc. We have recently acquired this application from Epic Pharma LLC, but unfortunately, we do not have all the paper format copies that were originally submitted from Nov 02nd 1998 t…

Requester: Dimple Bommanaboina - Rising Pharma Holdings, Inc

I would like to request the FDA, under the FOIA, to provide the drug approval package/FDA's assessment report for the following two approved ANDAs:_x000D_ _x000D_ Product Name & Strength: Carglumic Acid Tablets for Suspension, 200 mg_x000D_ ANDA# A213729_x000D_ Applicant Holder: NOVITIUM PHARMA LLC_x000D_ _x000D_ Prod…

Requester: Dimple Bommanaboina - Rising Pharma Holdings, Inc

Rising Pharma Holdings, Inc is the applicant holder for ANDA #219028 concerning Mesalamine Suppositories. We are requesting the FDA to provide the drug approval package/FDA assessment report for this ANDA, which received approval on April 14, 2025. Attached, please find the ANDA approval letter dated April 14, 2025,…

Requester: Dimple Bommanaboina - Rising Pharma Holdings, Inc

Form 483 from the FDA pre license inspection of the San Diego, California manufacturing facility for deramiocel for the company Capricor Therapeutics

Requester: Dilshan Seneviratna - Coronet Investments

Please provide the Form 483 issued by USFDA at Sun Pharma's formulations manufacturing facility at Halol, Gujarat, India (FEI #: 3002809586) after an inspection ending 13th June 2025.

Requester: Dhruv Jain - Avendus

As described in detail in the attached request, pursuant to the Freedom of Information Act, we request access to, or the production of, records, documents, reports, communications, and other correspondence pertaining to NE3107 (bezisterim, f/k/a HE3286), developed by BioVie Inc. Please see attached for complete list o…

Requester: Devyn R. Glass - Levi & Korsinsky LLP

I am requesting access to any and all records related to submissions made to the FDA between 1975 and 1985 regarding the evaluation, approval, or rejection of aluminum-based adjuvants (e.g., aluminum hydroxide, aluminum phosphate, or alum) as standalone immunological agents or injectable products, not part of a finish…

Requester: Dennis Field

I respectfully request access to all non-confidential data, reports, and test results included in FDA 510(k) submission K140714, specifically related to the material characterization and bench testing performed to demonstrate substantial equivalence. In particular, I am seeking information regarding: Material composit…

Requester: Denis Cengich - Ivory Graft Ltd

This is for my own organization Epic Clinical Research 500 West Main Street Suite 300 Lewisville, TX 75057. Need EIR report from sponsor Audit _x000D_ Name: Epic Clinical Research _x000D_ location: 500 West Main Street Suite 300 Lewisville, TX 75057_x000D_ FEI number 3024023690_x000D_ Type: Drug _x000D_ l

Requester: Demetria Timmons - Epic Clinical Research

Hi, I hereby request you to share the Form 483 for Human Drugs Inspection of Mankind Pharma Limited Sotanala. This site is located at Behror, India. The FEI is 3014150265. This Inspection happened on Apr 26, 2025.

Requester: Deepak Gupta

Hi, I hereby request you to share the Form 483 for Human Drugs Inspection of Les Produits Chimiques B.G.R. Inc. This site is located at Pointe-Claire, Canada. The FEI is 3000287309. The Inspection happened on Feb 28, 2025.

Requester: Deepak Gupta

Hi, I hereby request you to share the Form 483 for Human Drugs Inspection of Zochem ULC. The site is located at Brampton, Canada. The FEI is 3000104256. The Inspection happened on Jul 20,2023.

Requester: Deepak Gupta

A copy of the Sun Pharma Halol site 483 report from June 2025. In the past, we have received 483 reports quickly -- under the simple track -- and we would appreciate the same here. Thanks.

Requester: Debbie Cenziper - ProPublica

I would like to request a copy of Final Approval Letter for ANDA #204144; SITAGLIPTIN AND METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLET - ENDO OPERATIONS.

Requester: Debashis Mohanty - Lupin Pharmaceuticals, Inc

FDA meeting minutes related to an efficacy supplement approval received by ARS Pharmaceutical Operations, Inc. (also known as ARS Pharmaceuticals, Inc.) on March 5, 2025. We believe these documents to be held by the Center for Drug Evaluation and Research (CDER), the Center for Devices and Radiological Health (CDRH), …

Requester: Deb Koeneman - NDA Partners

From April 2, 2025 to May 30, 2025: All internal agency correspondence to or from the Director, Office of Management Director, or Office of Regulations Director of the Food and Drug Administration's Center for Tobacco Products, containing at least one of the following terms: \Supreme Court\"

Requester: David Williams - Taxpayers Protection Alliance Foundation

From April 1, 2025 to May 30, 2025: (1) All correspondence between Brian King and the Director, Office of Management Director, or Office of Regulations Director of the Food and Drug Administration's Center for Tobacco Products. (2) All internal agency correspondence to or from Food and Drug Administration Commissioner…

Requester: David William - Taxpayers Protection Alliance Foundation

Eli Lilly and Company is seeking the report or detailed results of the 24-week monkey study conducted with farletuzumab as described in Ebel W, Routhier EL, Foley B, et al. Preclinical evaluation of MORAb-003, a humanized monoclonal antibody antagonizing folate receptor-alpha. Cancer Immunity. 2007;7:6 (available at h…

Requester: David Records - Eli Lilly and Company, Corpora

Eli Lilly and Company is seeking the information from exatecan's nonclinical safety data (DX-8951f, Daiichi Pharmaceutical Co., Ltd, Japan). Specifically, studies that are referenced in Rowinsky, E.K. (2005). Preclinical and Clinical Development of Exatecan (DX-951f). In: Adams, V.R., Burke, T.G. (eds) Camptothecins i…

Requester: David Records - Eli Lilly and Company, Corpora

We are requesting all of the line item pivotal clinical study data provided to FDA to support PMA P150017, for both control and treatment arms. This is to help resolve FDA questions for PMA P230008. We are only requesting the line item pivotal clinical study data provided to FDA to support PMA P150017; however, if it …

Requester: David Pudwill - Mr Regulatory

I am a probation officer at Frank Crowley Courthouse in Dallas, TX. I am requesting the clinical trial report from 1990 that FDA \cleared\" PharmChem sweat

Requester: David Loza - Dallas County Community Supervision and Corrections Department

Please provide email correspondence between FDA Commissioner Marty Makary from email \Commissioner@fda.hhs.gov\" or any other email accounts he uses with any email with the domain \"@pinkston.co\" Please email these records to dlim@politico.com. This request is for journalistic (media) use. Please expedite the revi…

Requester: David Lim - Politico

This is a request made pursuant to the Freedom of Information Act. I write to request copies of publicly_x000D_ available documents that relate to Neumora Therapeutics, Inc.’s (“Neumora”) clinical trials for_x000D_ Navacaprant (NMRA-335140 or NMRA-140). Specifically, this request seeks all documents and_x000D_ c…

Requester: David Kaplan - Saxena White P.A.

Medtronic Visualase’s V2 submission (K250307); Freedom of Information (FOI) request for the corresponding submission content and correspondence, and the associated FDA reviewer's Notes, Memos, Letters, emails and/ or correspondence for the 510k submission, between the dates of 04/30/2025 and 06/10/2025

Requester: David H. Mueller - Monteris Medical

Dear FOIA staff:_x000D_ _x000D_ This is a request under the U.S. Freedom of Information Act for a copy of the records sought from the FDA and provided by the agency in request 2022-3546._x000D_ _x000D_ Please provide the responsive records in electronic format. Thank you for your work providing these public records._x…

Requester: Daniel Gilbert - The Washington Post

I request a copy of the 483 inspection associated with the facility below. _x000D_ We can approve $75.00. _x000D_ Date range: 3-15-2022-4-15-2022:_x000D_ _x000D_ Biogen International GmbH [Luterbach / Switzerland], Address: ATTISHOLZSTRASSE 11, LUTERBACH, SOLOTHURN CH-4542, SWITZERLAND (CHE), FEI: 3017081436, Inspecti…

Requester: Dana Powell - Dana Powell

I am requesting to receive all form 483's issued to Esteve Quimica, S.A. in Banyeres del Penedes, Spain (ESP) from 1/1/24-present. FEIN number: 3006616345 Category: Human Drugs ¿If no Form 483’s were issued, please confirm if an inspection has occurred in that time frame but no 483’s were issued, or if no inspe…

Requester: Dana Powell - Dana Powell

I request a copy of the individual case reports for certain cases listed on the FAERS Public Dashboard. _x000D_ _x000D_ The ID numbers for the requested case reports are: 24766373, 24802824, 24828018, 24902479, 24907513, 25013767, 25018590, 25018812, 24660653, 24239423, 24072680, 23572117._x000D_ _x000D_ Date Range is…

Requester: Dana Powell - Dana Powell

I request a copy of the 483 inspection associated with the facility below. _x000D_ _x000D_ Date Range is 5-15-2022 through 6-15-2022._x000D_ _x000D_ Fee approval is $75.00_x000D_ _x000D_ Sanofi S.r.l. [Anagni / Italy], Address: VIA VALCANELLO, 4, ANAGNI, FROSINONE 03012, ITALY (ITA), FEI: 3002807108, Inspection End Da…

Requester: Dana Powell - Dana Powell