Setter: A FOIA Getter

To Whom it May Concern: As permitted by the Freedom of Information Act (FOIA), I am hereby requesting the following document: Form FDA 483: Hoxworth Blood Center University of Cincinnati Ohio, United States End Dates of inspection: 08 Sep 2025 FEI: 1570969 Project Area: Blood and Blood Products Classification: VAI I c…

Requester: Molly Bowman - Clarivate Analytics Espana (SAU)

To Whom it May Concern: As permitted by the Freedom of Information Act (FOIA), I am hereby requesting the following document: Form FDA 483: NewYork-Presbyterian/Weill Cornell Medical Center New York, United States End Dates of inspection: 10 Sep 2025 FEI: 2470926 Project Area: Blood and Blood Products Classification: …

Requester: Molly Bowman - Clarivate Analytics Espana (SAU)

To Whom it May Concern: As permitted by the Freedom of Information Act (FOIA), I am hereby requesting the following document: Form FDA 483: Reading Hospital. Pennsylvania, United States End Dates of inspection: 30 Jul 2025 FEI: 2571104 Project Area: Blood and Blood Products Classification: VAI I confirm that Clarivate…

Requester: Molly Bowman - Clarivate Analytics Espana (SAU)

To Whom it May Concern: As permitted by the Freedom of Information Act (FOIA), I am hereby requesting the following document: Form FDA 483: Biomat USA, Inc Ohio, United States End Dates of inspection: 09 Dec 2025 FEI: 3024595229 Project Area: Blood and Blood Products Classification: VAI I confirm that Clarivate Analyt…

Requester: Molly Bowman - Clarivate Analytics Espana (SAU)

To Whom it May Concern: As permitted by the Freedom of Information Act (FOIA), I am hereby requesting the following document: Form FDA 483: Collaborative Laboratory Services, LLC- Saint Francis Campus Connecticut, United States End Dates of inspection: 20 Aug 2025 FEI: 1270168 Project Area: Blood and Blood Products Cl…

Requester: Molly Bowman - Clarivate Analytics Espana (SAU)

510(k) submission for K220317 and K051647.

Requester: Allen Castro - SYLKE, Inc

Requesting full submission of K892530 submitted on Aprill 11, 1989 and cleared on September 26, 1989. Attached is the clearance letter we have on file. The request is a copy of the entire submission.

Requester: Sarit Shah - Teleflex Incorporated

This FOIA request is in reference to Summary Basis of Approval (SBOA) documents request from USFDA for the following reference listed drug product: RLD name: VYKAT™ XR (diazoxide choline) extended-release tablets 25mg, 75mg and 150mg NDA: 216665 Following FDA Application Review Files are required from the USFDA: 1 Che…

Requester: Hindy Schiff, VP Regulatory Affairs and Compliance - Ascend Laboratories, LLC

Addendum to GRAS Notice 945 that addresses the removal of colbalt from the ingredient and any FDA correspondence responding to the addendum.

Requester: Stuart M. Pape - Polsinelli

Please provide the following inspection-related documents in electronic PDF format: The 483 (in electronic format) for the Biologics inspection of Cooper Institute for Advanced Reproductive Medicine, located at 7500 BeechNut St Ste 308, Houston, TX, 77074-4337, United States, inspection ending 10/29/2025 (FEI 30110063…

Requester: Joshua Boloy - Redica Systems

First Party Documentation Request for unredacted EIR for 24-25 October 2022 FDA Inspection (Medical Devices) of Sterigenics Charlotte Gamma facility located at 10811 Withers Cove Park Drive, Charlotte, NC 28278 FEI # 1000219637 Inspector: Gamal Norton District Office during inspection: Atlanta, GA No 483 issued. Pleas…

Requester: James Ragan - Sterigenics US, LLC

I am writing on behalf of Best Express Foods Inc, located at 1718 Boeing Way, Stockton, CA, to formally request copies of all records and any communication provided during the FDA inspections conducted at our facility on or around April 1, 2024, and May 31, 2025. We have an internal audit scheduled, and it is imperati…

Requester: JUAN OSUNA/ Best Express Foods Inc - BEST EXPRESS FOODS INC

I request copies of all FDA records related to the inspection of PIE Medical LLC conducted on or about February 2, 2015. This request includes, but is not limited to: FDA Form 482 (Notice of Inspection) FDA Form 483 (Inspectional Observations), including all drafts Establishment Inspection Report (EIR) Investigator no…

Requester: Ram Saroop - Edermy, LLC dba PIEMed

The form 483 inspection report or state EIR generated from the BIMO/Medical Devices & Rad Health inspection of the following foreign facility in the month of October, 2025: - Implantica CE Reflux Limited, Sir Temi Zammit Buildings, 0 Malta Life Sciences Park, Level, San Gwann, Malta - Operation date, report date, (las…

Requester: Mike Williams - The Capitol Forum

The form 483 inspection report or state EIR generated from the HF/Foods inspection of the following US facility in the month of October, 2025: - Flowers Baking Company of Morristown Warehouse/Thrift Store, 11029 Chapman Hwy, Seymour, TN, 37865-4808, United States - Operation date, report date, (last) date of inspectio…

Requester: Mike Williams - The Capitol Forum

Please provide the following inspection-related documents in electronic PDF format: The 483 (in electronic format) for the Food and Cosmetics inspection of Bactolac Pharmaceutical, Inc., located at 7 Oser Ave, Hauppauge, Ny, 11788-3811, United States, inspection ending 09/24/2025 (FEI 3000207006). The 483 (in electron…

Requester: Joshua Boloy - Redica Systems

Pursuant to 21 CFR §20.30 and the Freedom of Information Act (FOIA), Azurity Pharmaceuticals, Inc. ("Azurity") respectfully requests a unredacted copy of the drug product approval package for NDA#216903; PREVDUO® (neostigmine methylsulfate and glycopyrrolate) Injection, 1 mg and 0.2 mg/mL (3 mL prefilled syringe), whi…

Requester: Azurity Pharmaceuticals, Inc. - Azurity Pharmaceuticals, Inc.

I am requesting copies of the 510(k) submissions for the following premarket notifications: - K201302 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K201302 - K160552 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K160552 - K140312 https://www.accessdata.fda.gov/scripts/cdrh/c…

Requester: Sanika - Vena Vitals

Please provide the following inspection-related documents in electronic PDF format: The 483 (in electronic format) for the Biologics inspection of Biotest AG, located at Landsteiner Str. 5, Dreieich, 63303, Germany (DEU), inspection ending 06/20/2025 (FEI 3001034985). The 483 (in electronic format) for the Biologics i…

Requester: Jhan Ray Barril - Redica Systems

Please provide the following inspection-related documents in electronic PDF format: The 483 (in electronic format) for the Biologics inspection of Minaris Regenerative Medicine, LLC, located at 75 Commerce Dr, Allendale, New Jersey (NJ) 07401, United States (USA), inspection ending 09/29/2025 (FEI 3003407523). The 483…

Requester: Jhan Ray Barril - Redica Systems

FDA Establishment Inspection Report for KBI BioPharma1101 Hamlin Road Durham NC. The Pre License Inspection occurred in Sept 2024 for the product Datopotamab.facility FEI number is 3004638264

Requester: Geoff Sylvester - Merida Bioscience

We would like to request the formal/full RRA report relating to the FDA Remote Regulatory Assessment (RRA) conducted from February 23, 2022, to March 4, 2022, of our device manufacturing facility located Medidenta International, Inc., Las Vegas, NV, FEI # 1000113887.

Requester: Alfred Perez - Medidenta

Hi, Please provide current Package Insert and container labels for Retin-A cream (NDA# 019049, 017522, 017340). Thanks, Chandni patel

Requester: Chandni Patel - Torrent Pharma Inc.

We request a copy for correspondences of post or pre-submission between FDA and potential notifiers regarding brazzein or oubli fruit sweet protein.

Requester: Tina Wang - Oobli, Inc.

NADA 119-807Product: BEUTHANASIA-D SPECIAL- pentobarbital sodium and phenytoin sodium liquid (solution) Sponsor: formerly Schering-Plough Animal Health Corp.; present day: Intervet, Inc.Supporting Documents and Summary

Requester: Elizabeth Mason-Hein - Med-Pharmex, Inc.

Please share the Form 483 for Minaris Regenerative Medicine, LLC. Inspection details: • End Date: Sep 29, 2025 • Site: Minaris Regenerative Medicine, LLC, Allendale, United States • FEI Number: 3003407523

Requester: Sonika Shinghal - Sovish

I request all “agency records,” including but not limited to emails, memoranda, meeting notes, calendar invitations, talking points, attachments, or correspondence. Subjects of Search 1. Florida Senate Bill 1084 (2024), H.R.4368, S.3053, H.R.5728, or any other state or federal legislative or regulatory action regardin…

Requester: Olivia Villamagna - Animal Counsel

Please see attached letter

Requester: Amelia Ravelo - Ravelo Law Firm

Please provide the following inspection-related documents in electronic PDF format: The 483 (in electronic format) for the Animal Health inspection of Yantai Iris Pet Food Co., Ltd., located at Laishan Industrial Park, No. 27 Tonghe Road; Laishan, Yantai, China, inspection ending 12/14/2020 (FEI 3007922808). The 483 (…

Requester: Joshua Boloy - Redica Systems

I am requesting documentation (e.g Dear Investigator Letter OR Dear Health Care Provider) as to the reason/further details as to why recruitment of clinical study NCT06203210 has been halted in the US.

Requester: Toby Journeaux - EmPartners

To Whom It May Concern,I am submitting this request under the Freedom of Information Act (5 U.S.C. 552). Irespectfully request access to and copies of the following FDA records concerning Dinoprostone10 mg vaginal delivery system, also known as Propess. Requested Records:1. Full FDA-approved prescribing information hi…

Requester: Eyman Mohamed

Hello, My name is Colleen Al-Samarrie. I am a Technical Research Analyst with the nonprofit organization OMRI (Organic Materials Review Institute). We are writing a report for the USDA related to 15 injectable animal drugs. I am requesting from the FDA Center for Veterinary Medicine the 10 following FOI (Freedom of In…

Requester: Colleen Al-Samarrie (OMRI) - Organic Materials Review Insti

Please provide the following inspection-related documents in electronic PDF format: The 483 (in electronic format) for the Food and Cosmetics inspection of JARVICO, INC., located at 2046 Mckinley ST STE 7, Hollywood, FL, 33020-3166, United States, inspection ending 01/23/2025 (FEI 1000526064). The 483 (in electronic f…

Requester: Joshua Boloy - Redica Systems

A copy of any Complete Response Letter issued by FDA with respect to Mounjaro (tirzepatide) injection (NDA 215866) prior to the May 13, 2022 approval date of NDA 215866.

Requester: Aisha Evans - Hyman, Phelps & McNamara, P.C.

A copy of any Complete Response Letter issued by FDA with respect to ANDA 217234 for Liraglutide Injection, tentatively approved on September 11, 2025. Disclosure of any Complete Response Letters here is fully consistent with and will advance this Administration and FDA’s “embracing radical transparency,” as it did wh…

Requester: Aisha Evans - Hyman, Phelps & McNamara, P.C.

Dear FOIA Officer, Pursuant to the Freedom of Information Act (5 U.S.C. § 552), I hereby request access to the following record: The complete 510(k) Summary for premarket notification K936308 submitted by ANDRONIC DEVICES, LTD, including any publicly releasable attachments. I request that the record be provided in ele…

Requester: Eva Legramandi - Valuebiotech srl

I request copies of the 483 inspection reports for the locations listed below: 1. Fareva Amboise [Pocé-Sur-Cisse / France] Location: ZONE INDUSTRIELLE, 29 ROUTE DES INDUSTRIES, POCE- SUR-CISSE, 37530, FRANCE (FRA) FEI: 3000234005 Inspection End Date: 09/16/2025 Industry: Animal Health 2. Zhejiang Shenzhou Pharmaceutic…

Requester: Kristen Sellers - FOIA Professional Services

We respectfully request the 510(k) K110957 (M4 Monitor, SPECTRUM MEDICAL, LLP)

Requester: Tatjana Kuntschik - LivaNova Deutschland GmbH

I hereby request any information identifying the addressee of warning letter dated Sept. 9, 2025 to Master Pharmaceuticals Group, MARCS-CMS 715800, or providing a physical address. (I am attempting to locate an address for the service of process.)

Requester: Daniel Edelman

I am requesting full copies of the 510(k) premarket notification submissions for the following devices:K183559 - [https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K183559]K161579 - [https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K161579]K191031 - [https://www.accessdata.fda.gov/…

Requester: Sanika More - Vena Vitals

We are a Japanese company providing educational and training assistance to pharmaceutical companies.We would like to receive information on the following 2 Form 483s issued by the FDA to Japanese companies.Inspection ID:801168FEI Number:3004458336Legal Name:Morinaga Seika K KCity:OyamaInspection End Date:09/20/2012Ins…

Requester: Takashi SUGAYA - CM Plus Corporation

Any reports or investigations regarding Botox or imported illegal botox from China Korea Singapore or any reports involving Amber iund, Todd iund, April iund - Bowen dates 2024 - 2025 Utah or Idaho and Angela Hawkins or Angela Lynn iund

Requester: Angela Iund

Please provide the following inspection-related documents in electronic PDF format: The 483 (in electronic format) for the Animal Health inspection of Fareva Amboise, located at Zone Industrielle, 29 Route Des Industries, Poce-Sur-Cisse, 37530, France, inspection ending 09/16/2025 (FEI 3000234005). The 483 (in electro…

Requester: Jhan Ray Barril - Redica Systems

I am seeking all records for 510(k) clearance K250309 from BTL Industries Inc (Marlborough, MA) and their cleared device BTL-199 under the QPL product code. The 510(k) K250309 was cleared on August 7, 2025.

Requester: Randy Chavez - Regenesis Biomedical

All MedWatch case reports for adverse events associated with ketamine, sermorelin, nanadrolone, gonadorelin, nicotinamide adenine dinucleotide (NAD+) and ascorbic acid associated with Empower Pharmacy (FEI# 3021758709 and FEI# 3011887629).

Requester: Julian Gill - Houston Chronicle

Premarket notification records related to Gyder Surgical 510(k) K243387, cleared by the Agency on 1/29/2025.

Requester: Karyl Haskell - OrthAlign, Inc

510K submission documents of K112635 by Kimberly Clark

Requester: Shlomo Helvits - Albaad Massuot Itzhak LTD

To Whom it May Concern: As permitted by the Freedom of Information Act (FOIA), I am hereby requesting the following document: Form FDA 483: Veterans Affairs Palo Alto Health Care System. California, United States End Dates of inspection: 13 Feb 2025 FEI: 2971417 Project Area: Blood and Blood Products: Biologics Classi…

Requester: Molly Bowman - Clarivate Analytics Espana (SAU)

To Whom it May Concern: As permitted by the Freedom of Information Act (FOIA), I am hereby requesting the following document: Form FDA 483: Western Kentucky Regional Blood Ctr. Kentucky, United States End Dates of inspection: 23 Apr 2025 FEI: 1045410 Project Area: Blood and Blood Products: Biologics Classification: VA…

Requester: Molly Bowman - Clarivate Analytics Espana (SAU)

Pursuant to the Freedom of Information Act, 5 U.S.C. § 552 (as amended), we respectfully request copies of all and any records via electronic email (zip file(s)) or an electronic share file of the following records and documentation from the Food & Drug Administration (FDA) from January 1, 2025, to present: A copy of …

Requester: Joanna McCall - COGENCY GLOBAL INC.