Setter: A FOIA Getter

Good Day! We kindly request you to provide the following two (2) CSV files: 1. Listing of all INSPECTIONS from February 2025 to February 2026 (inclusive) with the following fields: FEI Number, Inspection Start Date, Inspection End Date, FMD-145 Date, Legal Name, Address, City, State Code, Zip Code, Country Name, FDA 4…

Requester: Jhan Ray Barril - Redica Systems

Good Day! Please list in CSV format the following information for all inspections from August 06, 2025 - March 06, 2026: Company Name, FEI Number, Inspection End Date, and CPGM Product Assignment Code. Thank you very much for your assistance!

Requester: Jhan Ray Barril - Redica Systems

We here request for electronical 483 form of Amphastar Pharmaceuticals, Inc. (FEI: 3002936358;3009805706 and 3003672088) for reference, we do not use for commercial purpose.

Requester: Zhang Yu - Fujian Genohope Biotech Ltd

We here request for electronical 483 form of Zhejiang Huahai Pharmaceutical Co., Ltd. (FEI: 3003999190; 3030356495; 3003885745 and 3025372239) for reference, we do not use for commercial purpose.

Requester: Zihan Zhu - Qingdao Qingke Biotechnology L

We request a modified version of FDA's publicly available Inspection Classifications spreadsheet to include the FEI, Address (Line 1), and Address (Line 2) for each inspection that occurred between October 1, 2011 - February 28, 2026. We request 3 additional columns to include classification, project area, and end dat…

Requester: Richard Anturiano-Chavez - Registrar Corp

On June 5, 2024, we submitted FOIA 2024-4921 requesting all publicly available cosmetic registration data submitted to FDA per new MoCRA requirements. On about July 24, 2024, we received two spreadsheets in response to FOIA 2024-4921: - FOIA 2024-4921 Cosmetic Product Facility Registration Report_Redacted - FOIA 2024-…

Requester: Richard Anturiano-Chavez - Registrar Corp

When FDA conducts a food facility inspection, the agency issues a form 483 listing observed violations. FDA publishes the frequency of the various observed violations: https://www.fda.gov/ICECI/Inspections/ucm250720.htm Form 483a is the equivalent of form 483 for FSVP inspections. We request a list of companies found …

Requester: Richard Anturiano-Chavez - Registrar Corp

FDA publishes weekly Enforcement Reports on its website (http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm) identifying all recalls monitored by FDA once they are classified according to the level of hazard involved. These reports are available as a downloadable CSV file which includes the following dat…

Requester: Richard Anturiano-Chavez - Registrar Corp

We request a spreadsheet identifying the firms that received FDA Warning Letters between October 1, 2011 - February 28, 2026 or the most recently available date, to include the following: Company FEI; Company Name; Company Address Line 1; Company Address Line 2; Company City; Company State/Region/Province; Company Pos…

Requester: Richard Anturiano-Chavez - Registrar Corp

Request the FDA application review files for the original approval of NDA 219683 (INLEXZO (gemcitabine hydrochloride) which had an action date of 09/09/2025. This was classified as a type 3 - new dosage form submission. Specifically, the request is for the following PDF files, if available: Product Quality Review(s); …

Requester: Jeffrey Yuan - JY Consultancy, LLC - JY Consultancy, LLC

Any and all records pertaining to the following: Affordatox, LLC; Affordatox; Radwa Omar; Radwa Clarissa Omar-Allen; Radwa Omar-Allen; Radwa Allen; Radwa Martin; Radwa Anderson; Radwa Omar Anderson; APRN License No. 3008054; RN License No. 1129844; Businesses located at or operating at 1445 US Hwy 25E, Middlesboro, KY…

Requester: Aalayah Purnell - Peterson Law Office

Gummi World is requesting the establishment inspection record (EIR) for its facility. Gummi World a FDA registered food facility located at 370 N Juniper Dr, STE 10, Chandler, AZ 85226. FEI number is 3016998691. The FDA food facility inspection ended on 3/2/2026 with Form 483 issued on the same day. The inspector name…

Requester: Gummi World - Gummi World, LLC

Good Day! Based on the inspections listing we requested and received from the FDA, kindly please provide the following inspection-related documents in electronic PDF Format: The 483 (in electronic format) for the Human Drugs inspection of Biovectra Inc., located at 24 Ivey Lane, Windsor, NS B0N 2T0, Canada (Can), insp…

Requester: Lloyd Ballesteros - Redica Systems

I'm looking to track the number of IND receipts (both commercial and research) to the FDA on a monthly basis (vs the data on the FDA website that I linked to below which is annual). I would like historical data by month, as well as monthly data though February '26. https://www.fda.gov/drugs/ind-activity/ind-receipts?u…

Requester: Mitchell Petersen - Eminence Capital

FEI 3012881787 - details as per attached letter FEI 3019558958 - details as per attached letter

Requester: Kevin Bagshaw - Amelia Knight Limited

Specific Information Requested I request confirmation of the following information for any and all PMTAs submitted by Turning Point Brands, Inc., or any subsidiary or affiliate entity, for oral nicotine pouch products marketed under the brand names FRE and/or ALP: 1. Whether FDA has received one or more PMTAs for nico…

Requester: Scott Miller - Scott Miller

Any email correspondence between your agency and anyone for the month of February 2026 with the surname Aandahl, Perring, Block, Brick, Kahlon, Balik, Cohodes, Eggert, Dorsey, Ma-Weaver, Hempton, Drose, Axler, Lamarco, Wiechert, Adrangi, Quadir, Vagner, Earl, Bonilla.

Requester: Joe O'Donnell - Canary Data

A list of all citizen's petitions filed in the period beginning February 01, 2026 and ending February 28, 2026.

Requester: Joe O'Donnell - Canary Data

A list of all form 483 inspections and their conclusions for the month of February 2026.

Requester: Joe O'Donnell - Canary Data

Any email correspondence between your agency and anyone for the month of February 2026 with the domain name @blueorcacapital.com, @viceroyresearch.com, @muddywaterscapital.com, @scorpioncapital.com, @alderlaneeggs.com, @thebearcave.com, @cablecarcapital.com, @brontecapital.com, @grizzlyreports.com, @bleeckerstreetrese…

Requester: Joe O'Donnell - Canary Data

Requesting a copy of a VAERS report completed on 02/27/2026. Report no. 1078000. I had completed the form online and did not print a copy. I am unable to return to the website and print a copy. Are you able to send a copy to my email listed above or provide me access through the VAERS reporting website?

Requester: Adam Mauel - CSL Plasma

Good Day! Based on the inspections listing we requested and received from the FDA, kindly please provide the following inspection-related documents in electronic PDF Format: The 483 (in electronic format) for the Human Drugs inspection of OPTIMUS PHARMA PRIVATE LIMITED, located at Plot No. 73/B & 73/B/2, Epip, Pashamy…

Requester: Lloyd Ballesteros - Redica Systems

CAP 1C0273 (Final rule 2005) - Lycopene • All sections and appendices of the original CAP submitted to FDA • All data, revisions and amendments submitted in responses to FDA’s questions and deficiency letters • All of FDA’s internal memorandums

Requester: Brian Head - Exponent, Inc.

1. All establishment inspection reports (“EIRs”) issued by the U.S. Food and Drug Administration (“FDA”) to ROVI Pharma Industrial Services S.A. and/or CorMedix, Inc., between January 1, 2018, and the present, including but not limited to the EIRs with the FDA Establishment Identifiers 3016688535, 3002989591, and 3007…

Requester: Christopher Tourek - Pomerantz LLP

I am requesting the full Center for Drug Research and Evaluation Integrated Review for Application #217369Orig2s000 for zuranolone (Zurzuvae NDA 217369) for major depressive disorder and postpartum depression. Specifically, I am requesting unredacted records the following sections (and the entire document, if possible…

Requester: Kevin Kennedy - Crescenz VA Medical Center

To Whom It May Concern: Pursuant to the Freedom of Information Act (FOIA), as amended, 5 U.S.C. §§ 552, et seq., Cogency Global Inc., hereby requests the names and affiliations of all attendees and the identity of all agenda items for each of CDER’s and OCGC’s listening sessions scheduled for February 27, 2026. Cogenc…

Requester: Joanna McCall - COGENCY GLOBAL INC.

Request copy of the SPL file and any FDA records for Cosmetic Registration for the following cosmetic facility: Name: O Doce Cheiro Industria De Cosméticos Ltda (Brazil) Address: Rua Senhor Jose Silotti, 180 - Vila Caraipe, Teixeira de Freitas - BA, 45.990-484 FEI: 3031351504 O Doce Cheiro Industria De Cosméticos Ltda…

Requester: John Gardiner (with B2Brazil LLC) - B2Brazil LLC

I would like to request an approval letter and label for ANDA #217953; Ipratropium Bromide Aerosol, metered; Inhalation EQ 0.021MG/INH (RLD: Atrovent HFA) of Armstrong Pharmaceuticals, Inc., which has received approval on February 23, 2026.

Requester: Debashis Mohanty - Lupin Pharmaceuticals, Inc.

I am requesting copies of the complete 483 inspection report received on 11/18-11/26/2025 for the facility listed below: Firm Name: Lonza Houston Firm Address: 14905 Kirby Drive, Houston, TX 77047 FEI Number: 3013629214 Commodity: Biologics Please provide the documents electronically by email if possible.

Requester: Kristen Sellers - FOIA Professional Services

Please share the Form 483 for Corza Medical Distribution GmbH, Austria Branch. Inspection details: • End Date: Sep 12, 2025 • Site: Corza Medical Distribution GmbH, Austria Branch, Linz, Austria • FEI Number: 3031599781

Requester: Sonika Shinghal - Sovish

DHHS/FDA/OAGS/DAO Contract No. 75F40124D00013-02 - FDA Security Installation and Maintenance

Requester: William Pannier - Pannier Law, PC

I am a US agent and I am looking for a list of all cosmetic facilities that list me as a US Agent. I have attached details of the information I'm requesting as well as several documents that are reference points to my company and credentials

Requester: Emily Matorin - Pragmatic Compliance Inc. (DBA

Mittal Consulting is requesting the full FOIA redacted 510(k) for the submission K172492. Link to 510(k) database listing: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K172492

Requester: Anya Bekhtel - Mittal Consulting

ON 1/17/26 I SUBMITTED AN INDIVIDUAL CASE SAFETY REPORT #2192826 TO THE FDA VIA YOUR ONLINE REPORT FORM. IT CAN ALSO BE IDENTIFIED BY THE HUMAN DIETARY SUPPLEMENT PRODUCT REPORT #486006. ON THE FORM I FILLED OUT ONLINE THE PROVIDED PHONE NUMBER TO CALL TO SPEAK WITH A PERSON ABOUT MY COMPLAINT IS 888-723-3366. I CALLE…

Requester: george matson

Dear Sir/Madam, I would like to request product Quality review for Epinephrine Solution; Intramuscular, Intravenous, Subcutaneous, 10 mg/10 mL (1 mg/mL) and 30 mg/30 mL (1 mg/mL). ANDA – 219239. Applicant – Gland Pharma Ltd. If you have any question or need further assistance to expedite this request, you can reach at…

Requester: Jaya Lakshmi Ayyagari - Dr. Reddy's Laboratories Inc.

I am looking for the docket associated with the regulation currently at 21 C.F.R. 172.715 but was originally located at 21 C.F.R. 121.1102. The regulation, titled “Calcium lignosulfonate.” is a food additive added through a petition filed by Marathon, a Division of American Can Company, Menasha, Wisconsin. The final r…

Requester: Seth A. Mailhot - Barnes & Thornburg LLP

Any FDA documentation (483, EIR, etc), in electronic format, related to FDA Inspection at Dr. Ashley Devonshire FDA Inspection 17 Nov - 20 Nov 2025. Looking for 483Ashley Devonshire, MD; Division of Allergy & Immunology Cincinnati Children’s Hospital Medical Center3333 Burnet Ave | MLC 2000 | Cincinnati, OH 45229 Than…

Requester: Global Key Solutions - Global Key Solutions

To Whom it May Concern: As permitted by the Freedom of Information Act (FOIA), I am hereby requesting the following document: Form FDA 483: Agena Bioscience, Inc. California United States End Dates of inspection: 13 Jun 2023 FEI: 3010962166 Project Area: Compliance: Devices Classification: OAI I confirm that Clarivate…

Requester: Pravallika Pravallik - Clarivate Analytics

To Whom it May Concern: As permitted by the Freedom of Information Act (FOIA), I am hereby requesting the following document: Form FDA 483: Datascope Corp. New Jersey United States End Dates of inspection: 15 May 2023 FEI: 3007965489 Project Area: Compliance: Devices Classification: OAI I confirm that Clarivate Analyt…

Requester: Pravallika Pravallik - Clarivate Analytics

All Enfamil records and ingredients

Requester: Lauren Willis

K231325 (Corplex P) entire 510(k) file (all sections of the premarket notification for K231325, including but not limited to: 510(k) summary, device description, executive summary and predicate comparison, performance testing -animal, -clinical, -bench, biocompatibility, sterilization and shelf life, labeling, indicat…

Requester: Susan Drapeau - Dark Horse Consulting

o the FDA Freedom of Information Act Office, Pursuant to the Freedom of Information Act, 5 U.S.C. § 552, I request access to records related to the FDA’s review of MEPACT (mifamurtide, formerly Junovan), including materials associated with the Oncologic Drugs Advisory Committee (ODAC) meeting held on May 9, 2007, and …

Requester: Erin Rose - Erin Rose

FOIA Request Unredacted approval package forTarpeyo (budesonide) reviews for the full approval, i.e., Suppl-3 Tarpeyo (budesonide)

Requester: Ellen Iwudibia - Biologics Consulting group

Requesting the releasablecopies of the FDA chemistry and toxicology review memoranda and all correspondence related to Food Contact Notification (FCN) 2159. FCN 2159 pertains to [1,1-biphenyl]-4,4-diol, polymer with1,1-sulfonylbis[4-chlorobenzene] (CAS Reg. No. 25608-64-4 and 25839-81-0) as a component used in the man…

Requester: Lauree Valverde - FOIA Request Services, LLC

To Whom It May Concern: The following request is about Orchid—sometimes called Orchid Health https://www.orchidhealth.com/, Orchid Biosciences, Inc https://www.orchidhealth.com/terms-of-service, or Orchid Bioscience, Inc https://opencorporates.com/companies/us_ca/4530928. it's a company focused on fertility -- specifi…

Requester: Caroline Haskins - N/A

Please see attached letter. Request for a copy of the Meeting Minutes and/or Agenda for the FDA Medical Policy & Program Review Council (“MPPRC”) meeting on August 27, 2025, insofar as they pertain to atropine and/or Sydnexis, Inc.’s NDA 219694 for atropine.

Requester: Irene Namata - Hyman, Phelps & McNamara

Complete copy of Food Additive Petition (FAP) 1318

Requester: Anne-Catherine Barrett - Steptoe LLP

Please provide Form 483 for INTECH Medical SAS in PDF format. Inspection details: • End Date: Apr 11, 2024 • Site: INTECH Medical SAS, Rang-Du-Fliers, France • FEI Number: 3002904345

Requester: Shalu Shrotiya

Hello. I would like to see information and discussion relating to this "collaborative review" . Any discussion relating to the 2018 citizens petition and decisions to revise SSRI and SNRI labels between the DP, DUOG, and OSE. Please include all documentation even if fully redacted. The quote below gives insight into t…

Requester: Evan Alexander

Subject: Freedom of Information Act Request – DS-7300a Clinical Hold and Hold-Lift Records To Whom It May Concern: Pursuant to the Freedom of Information Act, I request administrative records relating to the clinical hold affecting DS-7300a (Ifinatamab deruxtecan) in 2025–2026. Public reporting(1) and sponsor acknowle…

Requester: Pascal M. Besman - PharmaMar