Setter: A FOIA Getter

Hi, I hereby request you to share the Form 483 for the Inspection of Modavar Pharmaceuticals, LLC. The site is Located at Frederick, United States. The FEI is 3014525970. The Inspection ended on Nov 15, 2024.

Requester: Deepanshu Deepansh

Winning grants applications

Requester: Nick Inabnitt - Nexgenixai

Hello, I would like to request information related to Form FDA 483 issued for biologics manufacturing facilities during the period from 2025 through February 2026. Based on the FOIA guidance, I reviewed inspections classified as OAI and VAI in the FDA Data Dashboard, and it appears that the number of facilities involv…

Requester: Hyeong-Ho, Lee

I am requesting copies of the review documents and other publicly releasable regulatory materials for Vykat XR (diazoxide choline extended-release tablets), approved under NDA 216665. Specifically, I request the following documents: Clinical review Multidiscipline review Statistical review Pharmacology/toxicology revi…

Requester: Jules Bach - Tang Capital

Carnegie Pharmaceuticals LLC was audited by the US FDA from October 27, 2025 to October 31, 2025 for cGMP inspection for prescription drug manufacturing. Carnegie received a redacted EIR from FDA. We contacted the FDA auditor and they mention to request for unredacted EIR from FOIA pathway. Therefore, we are requestin…

Requester: Bhagyesh Pendse - Carnegie Pharmaceuticals LLC

FEI# 3002981536 had a QAI issued after an inspection on 12/5/2025. Resulting in an unpublished 483. Can you please provide the 483?

Requester: Caitlin Plate - HBI Amerilab Technologies Inc

Kindly requesting NDA application (redacted as necessary) for NDA 219683. We would like to review the required safety documentation that the Agency required in order to grant approval of this NDA as we are an academic research institution with limited resources and would like to also expand our research capabilities i…

Requester: Carrie Thomas - Moffitt Cancer Center

Cogency Global Inc. hereby requests a copy of FOIA Request Number FDA-FOIA-2025-12715, FDA-FOIA-2025-12669, and FDA-FOIA-2025-12660, including the request letter and the response and any related correspondence or memoranda.

Requester: Joanna McCall - COGENCY GLOBAL INC.

Please see attached letter. Request for a copy of any Complete Response Letter Issued for Scilex Holding Company’s sNDA for ELYXYB (NDA 212157), submitted Jan. 21, 2025, seeking an acute pain indication.

Requester: Jamerra Cherry - Hyman Phelps & McNamara, P.C.

Please see attached letter. Request for a copy of any Filing Letter or Refuse-To-File (RTF) Letter Issued for Scilex Holding Company’s sNDA for ELYXYB (NDA 212157), submitted Jan. 21, 2025, seeking an acute pain indication.

Requester: Jamerra Cherry - Hyman Phelps & McNamara, P.C.

Good Day! Based on the inspection 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 Safrel Pharmaceuticals LLC, located at 178 Ridge Rd Ste H, Dayton, NJ 08810-2532,…

Requester: Lloyd Ballesteros - Redica Systems

Shanghai Tai Heng Group Industry Co., Ltd. is the legal holder of DMF[28142].We are submitting this request under the Freedom of Information Act (FOIA) to obtain the 0016,0017 and 0018 with this DMF.

Requester: Shanghai Tai Heng Group Industry Co., Ltd. - Shanghai Tai Heng Group Indust

Good Day! Based on the inspection 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 MSD International GmbH (Singapore Branch), located at 60 Tuas West Drive, Singapo…

Requester: Jhan Ray Barril - Redica Systems

Please provide the following inspection-related documents in electronic PDF format: The 483 (in electronic format) for the Human Drugs inspection of Medpace Bioanalytical Laboratories LLC, located at 5365 Medpace Way # M Fl 2, Cincinnati, OH 45227-1543, United States, inspection ending 05/05/2017 (FEI 3010219001). Tha…

Requester: Joshua Boloy - Redica Systems

Please provide the following inspection-related documents in electronic PDF format: The 483 (in electronic format) for the Biologics inspection of Greater Delaware Valley Society of Transplant Surgeons, located at 401 N 3rd ST, Philadelphia, PA 19123-4101, United States, inspection ending 01/09/2026 (FEI 3000718079). …

Requester: Joshua Boloy - Redica Systems

Please provide the following inspection-related documents in electronic PDF format: The 483 (in electronic format) for the Biologics inspection of The Blood Connection, Inc., located at 5870 Core RD, North Charleston, SC 29406-6048, United States, inspection ending 01/09/2026 (FEI 3015985872). The 483 (in electronic f…

Requester: Joshua Boloy - Redica Systems

The entire Feed Additive Petition dossier which includes internal studies conducted in swine by Phillips Petroleum Company for use of dried Pichia pastoris in broiler chicken feed. FAP #2207, 1993.

Requester: Adrienne Bautista - Mars

EIR Nuvalent, Inc. (1 Broadway Floor 3 Cambridge, MA 02142-1100) FEI 3017297026 Inspection end date of January 14, 2026

Requester: Tina Gibson - Nuvalent Inc

I request access to and copies of records or internal communications about the safety of food additives like artificial dyes (Red 40, Yellow 5), preservatives, and high fructose from 2015 to the present. I would also like all links to those items to obesity, long-term health effects, and teen health impacts from 2020 …

Requester: Sara Jaime - Waubonsie Valley high school

Please send by email all AE correspondence and MedWatch reports on (sotatercept-csrk) WINREVAIR™ in the specified timeframe (01MAY25 to 30JUN25.)

Requester: Monica Martinez - Merck & Co., Inc.

I kindly request the complete reports (CIOMS) for the following FAERS Case ID numbers: 26467250, 26487977, 26454729, 26454728, and 26450518.

Requester: Gladys Gonzalez - Insmed Incorporated

Request for Establishment Inspection Report (EIR) – FEI # 3010892830 (August 11 – 22, 2025) Dear Sir or Madam: Pursuant to the Freedom of Information Act (FOIA), 5 U.S.C. § 552, I respectfully request a copy of the Establishment Inspection Report (EIR) for the inspection conducted at 4500 12th Street Extension, West C…

Requester: Caroline Hansen - Nephron SC, LLC

Please provide the following inspection-related documents in electronic PDF format: The 483 (in electronic format) for the Human Drugs inspection of Accupack Midwest, located at 1060 Meta DR, Cincinnati, OH 45237, United States, inspection ending 07/23/2025 (FEI 1000122754). The 483 (in electronic format) for the Huma…

Requester: Joshua Boloy - Redica Systems

Please provide the following inspection-related documents in electronic PDF format: The 483 (in electronic format) for the Human Drugs inspection of Sonia K. Kalirao, M.D., located at Healthcare Innovations Institute, LLC., 5441 N University DR STE 101, Coral Springs, FL 33067-4640, United States, inspection ending 01…

Requester: Joshua Boloy - Redica Systems

All correspondence regarding an announcement of 3/15 E. coli outbreak linked to raw milk cheddar cheese, suspected to be from Raw Farms, LLC. I'd like all internal agency emails, as well as those between FDA officials, and others at the CDC and California Department of Food and Agriculture. I am a member of the news m…

Requester: Susanne Rust - Los Angeles Times

Please provide the FDA-483 documents pertaining to Medical Device Inspection, for the following 2 firms: Difusion Technologies, Inc, 1624 Headway Cir, Austin, TX, United States, (FEI: 3009336374), inspection ending 2/12/2026; Turnco Tool & Instrument, Inc., 5080 E State Highway 29, Georgetown, TX, United States, (FEI:…

Requester: John Schleck - GMP Trends

Please provide the FDA-483 documents pertaining to Medical Device Inspection, for the following 3 firms: Gobiquity inc, 1321 Murfreesboro Pike Ste 202, Nashville, TN, United States, (FEI: 3010539401), inspection ending 2/12/2026; Seacole CRC, 13505 Industrial Park Blvd, Plymouth, MN, United States, (FEI: 3008363932), …

Requester: John Schleck - GMP Trends

Requesting the EIR Report from 2025 inspection FEI # 3012580398

Requester: Brian Bojar - Le Papillon Ltd

Please provide Form 483 for Lilly del Caribe, Inc. in PDF format. Inspection details: • End Date: Jan 30, 2026 • Site: Lilly del Caribe, Inc, Carolina, United States • FEI Number: 2619243

Requester: Shalu Shrotiya

All full clinical reviews, clinical pharmacology reviews, statistical reviews, and associated memoranda (beyond any summary review or approval letter already posted in Drugs@FDA), including detailed analyses from the OASIS 4 trial and bioavailability studies. All FDA-sponsor meeting minutes, teleconferences, emails, o…

Requester: Thiviyan Satheesh

Please see attached letter. Request for a copy of the Integrated Review underlying the Complete Response Letter issued to Corcept Therapeutics, Inc. for its NDA on December 30, 2025.

Requester: Jamerra Cherry - Hyman Phelps & McNamara, P.C.

This is a request under the Freedom of Information Act. I request copies of all documents in the possession of FDA, from October 1, 2025 – December 31, 2025, regarding products sold under the following names: Jamieson Jamieson Wellness Nutricorp Nutrawise Smart Solutions Body Plus Progressive Precision Iron Vegan yout…

Requester: Sherry Mowbray - Jamieson Laboratories Ltd.

INLEXZO NDA 219683 was approved on 9 September 2025. In order to support other country approvals, can you provide the Summary Basis of Approval for the INLEXZO approval?

Requester: Naana Awuku - Janssen Research & Development

All records held by the U.S. Food and Drug Administration relating to any past or current attempts to obtain U.S. regulatory approval, review, reinstatement, or evaluation of safflower-derived color additives, including safflower yellow, carthamus yellow, and any other coloring substances derived from Carthamus tincto…

Requester: Jay Howard - E&J Gallo Winery

I hereby am requesting to obtain the approval letter for an alternate API vendor submitted by Novel Laboratories, Inc. through an amendment on April 05, 2010, for ANDA # 090657- Clozapine Orally Disintegrating Tablets, 12.5 mg, 25 mg and 100 mg.

Requester: Venkata S Devarakonda - Novel Laboratories, Inc

Please see attached letter.

Requester: Mitchell M.Z. Twersky - Abraham, Fruchter & Twersky, L

FDA 483 for Marcia Cruz Correa and any results or answers from center.

Requester: Herminio Garcia

Please provide the following inspection-related documents in electronic PDF format: The 483 (in electronic format) for the Human Drugs inspection of Anesis Life, LLC, located at 16033 Leone DR, Macomb, MI 48042, United States, inspection ending 01/28/2026 (FEI 3025468170). The 483 (in electronic format) for the Human …

Requester: Joshua Boloy - Redica Systems

I request all FDA Establishment Inspection Reports (EIRs) for the following companies, including all domestic and international facilities, subsidiaries, predecessor entities, and any FDA-assigned FEI numbers, from inception to present: This request includes, but is not limited to: All EIRs for all FDA program areas, …

Requester: Skylar Armstrong-White

A list of FDA GMP inspections conducted from February 1, 2026, through February 28, 2026. Please include the following information: Firm Name, Full Street Address, FEI Number, whether or not a 483 was issued, the start and end date of the inspection, the inspection type (human drug or medical device GMP inspection), a…

Requester: John Schleck - GMP Trends

The records I'm requesting are to be used in an investigation I am conducting while working for my employer.

Requester: Terri Page - Liberty Mutual Insurance Compa

We seek records related to Carthamus as a color additive, including materials derived from the safflower plant (Carthamus tinctorius L.). This request includes, but is not limited to: • Correspondence (internal and external) • Meeting requests, agendas, minutes, and notes • Memoranda and briefing materials • Pre-submi…

Requester: John H. Cox - International Association of Color Manufacturers

I request electronic copies of the written notice of termination issued by FDA for the federal award associated with FAIN U01FD008451, NIH RePORTER project 11097541, to Duke University / Duke-Margolis, including any final written determination, cover letter, attachments, enclosures, and documents incorporated by refer…

Requester: Nicholas Harrison

Please provide the following inspection-related documents in electronic PDF format: The 483 (in electronic format) for the Human Drugs inspection of Element Materials Technology Oakland - Concord Inc., located at 2341 Stanwell DR, Concord, CA 94520, United States, inspection ending 01/30/2026 (FEI 3006616583). The 483…

Requester: Joshua Boloy - Redica Systems

Please provide the following inspection-related documents in electronic PDF format: The 483 (in electronic format) for the Human Drugs inspection of William C. Nabours, M.D., located at 751 Bayou Pines East DR STE L, Lake Charles, LA 70601-7196, United States, inspection ending 01/16/2026 (FEI 3041272861). The 483 (in…

Requester: Joshua Boloy - Redica Systems

I need our facility registration SPL file. Our facility is Shop Canaan, and our FEI number is 3014516086. Out MoCRA registration was originally obtained by a third party Registrar Corp on April 10th, 2024.

Requester: Jennifer Ayers - Shop Canaan

I would like to request Pharmacology and Biopharmaceutics information for ANDA#216418 of Mercaptopurine Oral Suspension in support for scientific research.

Requester: MANSI VEKARIYA - carnegie pharmaceuticals LLC

1. All drug and device recall database. 2. All drug shortages.

Requester: Ujjal Kumar Mukherjee - University of Illinois Urbana

Requesting information from the trial protocol for NCT04544449 (FENtrepid) -Requesting to know which "historical trials" are/were included in the meta-analysis for the synthesis method for this non-inferiority trial

Requester: Kaylin bower

Subject: FOIA Request – Final FDA-Approved Artwork/Labeling for NDA #006460 and ANDA #089454 Dear FOIA Officer: This is a request under the Freedom of Information Act, 5 U.S.C. § 552. I request copies of the final FDA-approved artwork and labeling associated with the following drug applications: • NDA 006460 • ANDA 08…

Requester: Bapi Reddy Eemana - BPI LABS, LLC