Setter: A FOIA Getter

A list of all entities that have declared any Gordon Food Service location as their FSVP importer

Requester: Jeremy Anderson - Gordon Food Service

Please provide the following inspection-related documents in electronic PDF format:_x000D_ _x000D_ The 483 (in electronic format) for the Medical Devices inspection of Cousin Biotech SAS, located at Allee des Roses, Wervicq-Sud, France, inspection ending 4/03/2025 (FEI 3003258310)._x000D_ _x000D_ - Thank you!

Requester: Jenny Adarog - Redica Systems

Please provide the following inspection-related documents in electronic PDF format:_x000D_ _x000D_ The 483 (in electronic format) for the Human Drugs inspection of Changzhou Pharmaceutical Factory, located at No.518 Laodong East Road, Changzhou, Jiangsu Province 213018, China, inspection ending 01/12/2024 (FEI 3002806…

Requester: Jenny Adarog - Redica Systems

Please provide the following inspection-related documents in electronic PDF format:_x000D_ _x000D_ The 483 (in electronic format) for the Animal Health inspection of Azevedo Dairy #1, located at 5345 Oak Ave, Merced, CA, 95341-8000, United States, inspection ending 6/14/2021 (FEI 3018308762)._x000D_ _x000D_ The 483 (i…

Requester: Jenny Adarog - Redica Systems

Please provide the following inspection-related documents in electronic PDF format:_x000D_ _x000D_ The 483 (in electronic format) for the Human Drugs inspection of Medefil, Inc., located at 250 Windy Point Drive, Glendale Heights, Illinois (IL) 60139, United States (USA), inspection ending 4/21/2025 (FEI 3001677091)._…

Requester: Jenny Adarog - Redica Systems

Please provide the following inspection-related documents in electronic PDF format:_x000D_ _x000D_ The 483 (in electronic format) for the Human Drugs inspection of Tedor Pharma Inc., located at 400 Highland Corporate Drive, Cumberland, Rhode Island (RI) 02864, United States (USA), inspection ending 6/05/2025 (FEI 3003…

Requester: Jenny Adarog - Redica Systems

Please provide the following inspection-related documents in electronic PDF format:_x000D_ _x000D_ The 483 (in electronic format) for the Human Drugs inspection of Teva Biotech GmbH, located at DORNIERSTRASSE 10, ULM, 89079, GERMANY (DEU), inspection ending 3/21/2025 (FEI 3007817154)._x000D_ _x000D_ - Thank you!

Requester: Jenny Adarog - Redica Systems

Please provide the following inspection-related documents in electronic PDF format:_x000D_ _x000D_ The 483 (in electronic format) for the Food and Cosmetics inspection of Del Valle Import & Export 3, Inc., located at 2824 E 54th St, Vernon, CA, 90058-3632, United States, inspection ending 11/21/2024 (FEI 3013996624)._…

Requester: Jenny Adarog - Redica Systems

Please provide the following inspection-related documents in electronic PDF format:_x000D_ _x000D_ The 483 (in electronic format) for the Animal Health inspection of Bradley J. Olek Farm, located at 12803 140th Ave N, Felton, MN, 56536-9304, United States, inspection ending 6/28/2023 (FEI 3002565852)._x000D_ _x000D_ T…

Requester: Jenny Adarog - Redica Systems

Hello! _x000D_ Please list in CSV format the following information for all inspections since September 10, 2024 to June 10, 2025: Company Name, FEI Number, Inspection End Date, and CPGM Product Assignment Code._x000D_ _x000D_ Please reach out to us if you have any questions. We thank you in advance._x000D_

Requester: Jenny Adarog - Redica Systems

Please provide the following inspection-related documents in electronic PDF format:_x000D_ _x000D_ The 483 (in electronic format) for the Medical Devices inspection of Richard-Allan Scientific Company, located at 4481 Campus Dr, Kalamazoo, MI, 49008-2590, United States, inspection ending 4/23/2025 (FEI 1831638)._x000D…

Requester: Jenny Adarog - Redica Systems

Please provide the following inspection-related documents in electronic PDF format:_x000D_ _x000D_ The 483 (in electronic format) for the Medical Devices inspection of Brain Tunnelgenix Technologies, located at 17501 Biscayne Blvd Ste 470, Aventura, FL, 33160-4806, United States, inspection ending 1/31/2025 (FEI 30080…

Requester: Jenny Adarog - Redica Systems

Please provide the following inspection-related documents in electronic PDF format:_x000D_ _x000D_ The 483 (in electronic format) for the Medical Devices inspection of Invisian Medical, LLC., located at 7301 Mission Rd Ste 215, Prairie Village, KS, 66208-3031, United States, inspection ending 3/31/2025 (FEI 3023158661…

Requester: Jenny Adarog - Redica Systems

Please provide the following inspection-related documents in electronic PDF format:_x000D_ _x000D_ The 483 (in electronic format) for the Food and Cosmetics inspection of JX Restaurants, Inc., located at 64 Weldon Pkwy, Maryland Heights, MO 63043-3202, United States, inspection ending 10/03/2024 (FEI 3021116553)._x000…

Requester: Jenny Adarog - Redica Systems

The 483 (in electronic format) for the Biologics inspection of Octapharma Produktionsgesellschaft Deutschland mbH, located at Wolfgang-Marguerre-Allee 1, Springe, 31832, Germany, inspection ending 3/21/2023 (FEI 3016855360)._x000D_ _x000D_ - Thank you!

Requester: Jenny Adarog - Redica Systems

Please provide disclosable, redacted EIRs in electronic format (.pdf) that have been released since April 1st, 2025. Please exclude any previous documents shared with Redica Systems. Please feel free to contact us (records@redica.com) to discuss any questions or issues which may result prior to or during the processin…

Requester: Jenny Adarog - Redica Systems

All deaths and adverse events reported for Z-pack/Aziithromycin (all brands and all dose levels) for all ALL ages in the US. Please include any FDA charts that show trends. Please include any black box or updates to black box warning post 2013.

Requester: Jennifer M. Schilcher

Please be advised our office represents Susan LaMancusa-Shapiro with respect to a Vaccine Injury Compensation Program (VICP) claim to be filed in the U.S. Court of Federal Claims. This is not a medical negligence case or a product liability case. In short, the VICP is a no-fault alternative to the traditional t…

Requester: Jeffrey S. S. Pop & Associates

I request a copy of the full 510(k) premarket notification submission for the CAM Patch device submitted by Bardy Diagnostics, Inc., under 510(k) number K172234. Please include all non-confidential materials such as the 510(k) summary, device description, indications for use, predicate comparison, performance testing …

Requester: Jeff Sherman - Endpoint Partners

I request copies of the following FDA submissions by Apple Inc., excluding any confidential commercial information or trade secrets:_x000D_ _x000D_ De Novo Classification Request DEN180044: Pertaining to the ECG App on Apple Watch._x000D_ _x000D_ 510(k) Premarket Notification K213971: Pertaining to the Atrial Fibrilla…

Requester: Jeff Sherman - Endpoint Partners

I request a copy of the full 510(k) premarket notification submission for the Zio XT device submitted by iRhythm Technologies, Inc., under 510(k) number K102529. Please include all non-confidential materials such as the 510(k) summary, device description, indications for use, predicate comparison, performance testing …

Requester: Jeff Sherman - Endpoint Partners

I request a copy of the full 510(k) premarket notification submission for the Zio AT device submitted by iRhythm Technologies, Inc., under 510(k) number K240029. Please include all non-confidential materials such as the 510(k) summary, device description, indications for use, predicate comparison, performance testing …

Requester: Jeff Sherman - Endpoint Partners

I request a copy of the full 510(k) premarket notification submission for the VitalPatch device submitted by VitalConnect, Inc., under 510(k) number K161014. Please include all non-confidential materials such as the 510(k) summary, device description, indications for use, predicate comparison, performance testing summ…

Requester: Jeff Sherman - Endpoint Partners

I request a copy of the full 510(k) premarket notification submission for the KardiaMobile device submitted by AliveCor, Inc., under 510(k) number K172601. Please include all non-confidential materials such as the 510(k) summary, device description, indications for use, predicate comparison, performance testing summar…

Requester: Jeff Sherman - Endpoint Partners

Please provide the document sent to Heritage Life Sciences, NDA holder for CLOZARIL (clozapine), titled \REMS Modification/Safety Labeling Change Notification\" and dated February 24

Requester: Jed Johnson - VUMC

Name: Adare Pharmaceuticals, Inc._x000D_ Location: 845 Center Dr, Vandalia, Ohio 45377, United States_x000D_ FEI Number: 1525864_x000D_ EI start: 02/18/2025_x000D_ EI End: 02/25/2025_x000D_ _x000D_ We are requesting a Redacted Establishment Inspection Report (EIR).

Requester: Jean Paul Twagirumuhuza - Adare Pharma Solutions

we are submitting a Freedom of Information Act (FOIA) request under 5 U.S.C. § 552 for the following documents related to ANDA 018027, concerning LITHOBID (300 mg), submitted by ANI PHARMS, LLC:_x000D_ _x000D_ 1. Chemistry, Manufacturing, and Controls (CMC) Review_x000D_ 2. Microbiology Review_x000D_ 3. In Vitro Equi…

Requester: Jarvis Fang - Jarvis Fang

FDA full report for the shipment in which the FDA detected salmonella ( INV#123932, PO#01-C8308, Customs entry#FY1-4066142-9)

Requester: JANMARIE TUYAC - JANMARIE TUYAC

calendar records for FDA-CVM employee Charlotte Conway, dates 09.01.24-09.30.24

Requester: Janine Deville - [no org]

510(k) K242543

Requester: Jane Guo - Howmedica Osteonics Corp.

I wish to receive the FDA Approval letter for Dehydrated Alcohol for ANDA #219444 (Breckenridge).

Requester: Jan Jiskra - Synthon B.V.

I am seeking any and all records related to inspections at the Gulbrandsen Technologies facility located at 183 Gulbrandsen Road, Orangeburg SC 29115. This includes 483's and EIRs.

Requester: James Carson - Gulbrandsen Technologies

• Name of the egg producer _x000D_ August Egg Company_x000D_ GEMPERLE FAMILY FARMS_x000D_ • Approximate date of the incident/report; June 6. 2025 FDA publish date. Eggs distributed from 2/03/2025 to 5/15/2025 with sell by dates 3/04/2025 to 6/04/2025 in Save Mart, FoodMaxx, Lucky, Smart and Final, Safeway, Raleys…

Requester: James Bennett, Paralegal - Bremer Whyte Brown & O'Meara 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: 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: James Akingbasote - Intertek Health Sciences Inc

I am requesting my firms EIR for the following audits_x000D_ 2010, 2011, 2017, and 2021. We are in possession of the 2013 report.

Requester: Jacqueline Jean-Baptiste - millar Inc., Millar Instrument

Hepatobiliary reactions to vorasidenib. Case ID numbers 25133358, 25123401, 25013471, 25019005, 24994676, 24873236, 24717249, 24613490, 24558493, 24634677, 24450023, and 24652877.

Requester: Jacob Lau - Hoag Hospital

Hepatobiliary reactions to vorasidenib

Requester: Jacob Lau - Hoag Hospital

This is a first party request for an unredacted copy of the EIR record from September 2022 for our organization: Rockwell Medical, 30142 Wixom Rd. Wixom, MI 48393 FEI 3001236991. Inspection end date of 9/9/2022. This was a \For Cause\" inspection."

Requester: Jackie Fagerlie - Rockwell Medical

Blatant ad running forever advertising NEW relief for chronic lung congestion. The ad never ends. _x000D_ _x000D_ Respiratory Therapist_x000D_ Elizabeth Moffett_x000D_ One Of North America's Leading Respiratory Therapists & Author Of Best Selling Books 'Conquering COPD' & 'Breathe Better'

Requester: Jack J. Bechtold

We, Formosa Pharmaceuticals Inc., are the NDA holder of NDA #218158. We respectfully request access to the non-redacted version of the FDA review files for NDA 218158 to support our global registration efforts. Specifically, we are requesting the following FDA review documents associated with NDA 218158: 1. Product Qu…

Requester: I-Ting Ho - Formosa Pharmaceuticals, Inc.

Copies of any and all complaints received by the FDA Bad Ad Program referenced in the May 29, 2025 Warning Letter to Sprout Pharmaceuticals and any correspondence related thereto.

Requester: Irene Namata - Hyman, Phelps & McNamara

A copy of the Tentative Approval letter for ANDA 218905, Tafamidis Capsules, 61 mg, dated April 21, 2025.

Requester: Irene Namata - Hyman, Phelps & McNamara

Pursuant to the Freedom of Information Act, I request email metadata only (To, From, Date, Subject line) for emails sent or received by Dr. Donald A. Prater, Principal Deputy Director for Human Foods, between January 1, 2025, and June 17, 2025._x000D_ _x000D_ The search should include emails that contain any of the fo…

Requester: Iain Irwin - Noir News

Pursuant to the Freedom of Information Act, I request the email metadata only (To, From, Date, Subject line) for emails sent or received between January 1, 2025, and the June 17, 2025 by personnel at the:_x000D_ _x000D_ Center for Food Safety and Applied Nutrition (CFSAN), and_x000D_ _x000D_ Center for Drug Evaluation…

Requester: Iain Irwin - Noir News

Total of 3 Establishment Inspection Reports_x000D_ [1. Company: Revance Therapeutics, Inc. (Newark, CA; FEI: 3007772056) // Inspection Date: Jun. 21 to Jul. 02, 2021]_x000D_ [2. Company: Revance Therapeutics, Inc. (Newark, CA; FEI: 3007772056) // Inspection Date: Jul. 11 to Jul. 15, 2022]_x000D_ [3. Company: Hugel, In…

Requester: Hanson Jeon - Medytox Inc.

Final response provided for 2025-2129, requesting Text messages preserved for FOIA for January 2025 for Charlotte Conway, FDA CVM

Requester: Hannah Boudreaux

calendar records for FDA-CVM employee Charlotte Conway, dates 01.01.25-01.31.25

Requester: Hannah Boudreaux

All email records for FDA CVM employee Charlotte Conway containing the key search term: AAFCO. (Date range for records search is: 04.01.2025-04.30.2025). All email records for FDA CVM employee Charlotte Conway containing the key search term: AAFCO. (Date range for records search is: 05.01.2025-05.31.2025)

Requester: Hannah Boudreaux

calendar records for FDA-CVM employee Charlotte Conway, dates 04.01.25-04.30.25

Requester: Hannah Boudreaux