Setter: A FOIA Getter

Drug Approval Package: DATROWAY. Company: Daiichi Sankyo, Inc. Application number: 761394Orig1s000. Approval Date: 1/17/2025. I would like to request a more detailed assessment of the BLA submission, only for the Module 3 part, CMC, which is not integrated in the public Product Quality Review

Requester: Ana Isabel Casado - Ana Isabel Casado

Please provide EIR report for the inspection done in Ojas Multispeciality Hospital, Ravet, Pune from 29/08/2022 to 02/09/2022. Site has not yet recieved EIR report for the same. Inspection type - Drug

Requester: Leena Rathi - Ojas Multispeciality Hospital

Inspection Records for PI: Dilawar Ajani FEI 3007134943 Location: Houston, TX, USA Inspection type: Drugs Inspection end date 16 Dec 2024 Inspection ID 1257425

Requester: Stacey Hayes - Arrowhead Pharmaceuticals

Inspection Records for PI: Dilawar Ajani FEI 3007134943 Location: Houston, TX, USA Inspection type: Drugs Inspection end date 16 Oct 2008 Inspection ID 542315

Requester: Stacey Hayes - Arrowhead Pharmaceuticals

Duplicate of FDA-FOIA-2026-4022

Requester: Christen A. Wilson

FF Request 2026-2000

Requester: Kareen Ejoh - Kelley Drye & Warren, LLP

Please provide us with any Form 483’s received by Lonza in Visp (FEI Number: 3002930340) from September 1, 2025 to April 20, 2026.

Requester: Kareen Ejoh - Kelley Drye & Warren, LLP

Please consider this request for a copy of the 06/13/2025 Tentative Approval letter for ANDA No. 219231 for Carbidopa; Levodopa (generic drug). Please consider this request for a copy of the 03/06/2026 Effective Approval letter for ANDA No. 218459 for Siponimod (generic drug). Please consider this request for a copy o…

Requester: Gorakhnath Tambe - IPD Analytics

All forms 3542 submitted to NDA No. 208114 that disclose patent information for U.S. Patent No. 11,236,328.

Requester: Aaron Savit - Axinn Veltrop & Harkrider

FF Request 2026-1013

Requester: Sonal Patel - Alvogen

Please can I request two Form 483s issued to Lonza: FEI Number: 3002930340 for Lonza AG, Lonza Strasse 2 FEI Number: 3001451441 for Lonza Biologics Inc, 101 International Drive

Requester: JP Morgan - J.P. Morgan

Requesting Form 483 for Inspection ID: 1290872 (Type: Drugs) with an Inspection End Date: 09/19/2025 for the following company: Syn-Tech Chemical & Pharm. Co., Ltd. 168 Kaiyuan Rd., Xin Ying Qu Tai Nan Shi, 730 Taiwan Thank you-

Requester: Matthew Shelton - Sheffield Pharmaceuticals

I am requesting to receive the summary case reports for the following case ID from the AEMS system: 26565146. The drug name is Qelbree and the date range is 4/1/26 to date the request is processed.

Requester: Caitlin Crawford

Subject: Freedom of Information Act Request – YL201 (B7-H3 ADC) / DeLLphi-310 (NCT06898957) Safety-Related Halt Records To Whom It May Concern, Pursuant to the Freedom of Information Act, I request administrative records relating to safety-related actions affecting studies involving YL201 (a B7-H3 antibody-drug conjug…

Requester: Pascal Besman - PharmaMar

Subject: FOIA Request for Form FDA 483 – Bio-Thera Solutions. Ltd. Dear FOIA Officer, Pursuant to the Freedom of Information Act, I respectfully request a copy of the final Form FDA 483 issued to the following facility: Facility Name: Bio-Thera Solutions. Ltd. FEI number: 3017231337 Facility Location: Guangzhou, Guang…

Requester: Fang Liu

Subject: FOIA Request for Form FDA 483 – Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd Dear FOIA Officer, Pursuant to the Freedom of Information Act, I respectfully request a copy of the final Form FDA 483 issued to the following facility: Facility Name: Nanjing King-Friend Biochemical Pharmaceutical Co., Lt…

Requester: Fang Liu

Dear Sir/Madam, I am writing to request a copy of the Establishment Inspection Report, including Form FDA 483 (if issued), for the following facility under the Freedom of Information Act (FOIA): Facility Name: King George Hospital / Andhra Medical College Address: Maharanipeta, Visakhapatnam, Andhra Pradesh 530002, In…

Requester: ORIGIN CR Services - Origin CR Services

U.S. FDA concluded an inspection at Lupin Ltd.'s manufacturing facility located in Somerset, New Jersey, U.S.A. The inspection was conducted from April 13, 2026 to April 17, 2026 and closed with the issuance of a Form-483 with three observations. Kindly provide us with this Form-483.

Requester: Kushal Chovatia - Nomura

Request for MedWatch Report for Product Case ID: 26229330 Suspect Product: Copiktra (Duvelisib) Reaction: Peripheral T-Cell Lymphoma Unspecified; Off Label Use Sex: Male Patient Age: Unknown

Requester: Gnana Velaga - UNITED BIOSOURCE LLC

Request for MedWatch Report for Product Case ID: 26251206 Suspect Product: Copiktra (Duvelisib) Reaction: Off label use Sex: Female Patient Age: Unknown

Requester: Gnana Velaga - UNITED BIOSOURCE LLC

We, Sechrist Industries, Inc., would like to request a copy of 510(k), K240569, under the Freedom of Information Act.

Requester: Sechrist Industries, Inc.

• Traceback investigation reports and summaries • Chain-of-custody documentation and distribution flow diagrams • Traceback worksheets and analytical mapping tools used to identify product movement through the supply chain • Records identifying grower, shipper, broker, distributor, and retail or foodservice distributi…

Requester: Charles J. Homiler, Jr. - Homiller Law Firm

Memo associated with the non-forfeiture decision made regarding 180-days status for ANDA 22341 posted on 7/8/2024.

Requester: Caroline Hoffmann

Letter to J. Vaughn (Actavis) from D.Toyer Mckan, (Division of Project Management/Office of Regulatory Operations/OGD) on Nov. 13, 2018, as referenced in footnote 96 of the forfeiture memo dated 1/8/2025 and relating to ANDA 208959.

Requester: Caroline Hoffmann

I would like to request Bioequivalence and Biopharmaceutics information for ANDA#216418 Mercaptopurine Suspension, 20 mg/mL by Hikma Pharmaceuticals for the R&D purpose.

Requester: Mansi Vekariya - Carnegie Pharmaceuticals LLC

As the MAH, Vertex Pharmaceuticals is requesting the complete unredacted source information available for FDA FAERS case ID# 26570826 (Product/Drug name: Journavx). Vertex Case ID: 2026-007267. Thank you.

Requester: David Jaimes (Dept: Global Patient Safety) - Vertex Pharmaceuticals

US Food and Drug Administration (USFDA) conducted an inspection at Cipla Limited's manufacturing facility in Verna, Goa, from April 6 to April 17, 2026. Kindly share the Form 483. The FEI of the site is 3004081307.

Requester: Dr. Bhawna Ag - Code Carbon

FF Request 2020-6725

Requester: Christopher Womack - FOIA Document Source

Dear FOIA staff: This is a request under the U.S. Freedom of Information Act for copies of the individual case safety reports, including event narratives, associated with the following adverse event case IDs: 26543954 26528859 26499831 26477773 26428827 26424203 26409299 26341061 26286286 26034567 26011566 25841529 Pl…

Requester: Daniel Gilbert - CBS News

I need discussions/ medical reviews regarding this labeling amendment between DP, DUOG and OSE. On May 10, 2018, the Agency received a Citizen’s Petition (CP, docket # FDA-2018-P-1846) from Data Based Medicine Americas, Ltd., requesting that FDA immediately revise all SSRI and SNRI labeling.• After a careful collabora…

Requester: Evan Alexander

FF Request 2024-10011

Requester: Christopher Womack - FOIA Document Source

I wish to inspect and obtain copies of the following records: APTEV0436 Pharmaceutical Study monitored by FDA The search for the records can be limited to the following date range: September 28th, 2024 to Present. I have attached the following documents or items to aid you in your search for records: Docket NO FDA 202…

Requester: Helmut Koeckert

I am writing.regarding.my pendingFOIA request, Control No. 2025-1062, concerning. records related to AT-007 (govorestat), Applied Therapeutics. For your awareness, I have identified several related FOIA requests reflected in FDA FOIA togs that appear to concern overta pping subject matter, including FDA's review and d…

Requester: Gillian Sapia - Galactosemia Foundation

Please provide the following inspection-related documents: 483s, EIRs, and 483 Responses released in 03/01/2026 to 03/31/2026.

Requester: Neelima Neelim - Infodesk Inc

Please provide the form 483 for Par Formulations Private Limited, Dhar, India. FEI Number: 3016268582 for the inspection that ended on 26 March, 2024

Requester: Sahil Arora

I am requesting the following cases: 1. Case ID - 26467250; Product - Brinsupri/Brensocatib; Reactions - Pneumonia Pseudomonal; Outcome-died; Latest FDA Rec'd Date - 3/5/2026 2. Case ID - 26487977; Product - Ethambutol; Active ingredients - Ethambutol Hydrochloride;Brensocatib;Rifampin;Azithromycin; Reactions - Hyperk…

Requester: Gladys Gonzalez - Insmed Incorporated

This is a First party request. Authorization attached. I am requesting unredacted first-party FDA inspection records for my company, specifically the FDA Form 482 for the Human Foods Program. Facility: Santa Monica Seafood DBA Chesapeake Seafood 535 Harbor Lane, San Diego, CA 92101 The inspection was performed 8/1/202…

Requester: ANDREW GIBULA - Santa Monica Seafood

Please provide the FDA-483 documents pertaining to Human DRUG Inspection, for the following firm: Purolea Cosmetics Lab, 12782 Currie Ct, Livonia, Michigan, United States, (FEI 3011669383), inspection ending 10/30/2025.

Requester: John Schleck - GMP Trends

I am an investment professional requesting the FAERS case records for SLNO Vykat XR, case number 26571698. If available, please share both the Excel and PDF files and send them to quinn.lin@point72.com.

Requester: Quinn Lin - Sirenia Capital

FF Requests: FDA-FOIA-2026-2312, FDA-FOIA-2026-1430, FDA-FOIA-2026-1126, FDA-FOIA-2026-1127, FDA-FOIA-2026-1128

Requester: Orca1 Orca - Orca1 Digital Intelligence, LL

Pursuant to the Freedom of Information Act (5 U.S.C. § 552), I request a copy of the FDA Form 483 (Inspection Observations), including any associated exhibits or attachments, issued following the inspection of the following facility: • Firm Name: Purolea Cosmetics Lab • Address: 12782 Currie Ct, Livonia, Michigan 4815…

Requester: Adam Pinkert - Quality Assured AI

We request a spreadsheet detailing the number of Food Canning Establishments (FCE) that are registered with FDA in each country as of March 31, 2026, to include the name of the country and the number of Food Canning Establishments registered in that country. We also request the list for domestic registered facilities …

Requester: Richard Anturiano-Chavez - Registrar Corp

Seeking any and all Novartis responses to the FDA Letter sent to Novartis dated 9-9-2025 regarding the DTC television advertisement titled "KSM DTC My Time My Way :60 TC Campaign Expansion 11-24" (FA-11225957) for Kesimpta (ofatumumab). This letter from the FDA to Novartis dated 9-9-2025 was 2 pages and contained 1 si…

Requester: Kaylin M. Bower

Dear FOIA Officer, This is a request under the Freedom of Information Act, 5 U.S.C. § 552. I am requesting a copy of the individual case safety report (ICSR), including all available narratives, attachments, and associated records, for the following adverse event case contained in the FDA Adverse Event Monitoring Syst…

Requester: Nina Vekima - Lumicell

Unredacted copy of all Product Quality Reviews posted on Drugs@FDA at the weblink https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/761384Orig1s000ChemR.pdf .

Requester: Marilynn Whitney - Covington & Burling LLP

All IND applications for Spruce Biosciences in relation to the investigative new drug Tralesinidase alfa enzyme replacement therapy (TA-ERT), Formerly known as Allievex AX-250 and Biomarin BM-250. In addition to any available type B meeting summaries between the FDA and Spruce Biosciences.

Requester: Don R. McConnell

Unredacted copy of the Multi-Discipline Review posted on Drugs@FDA at the weblink https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/761384Orig1s000MultidisciplineR.pdf.

Requester: Marilynn Whitney - Covington & Burling LLP

Unredacted copy of the Risk Assessment and Risk Mitigation Review(s) posted on Drugs@FDA at the weblink https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/761384Orig1s000RiskR.pdf.

Requester: Marilynn Whitney - Covington & Burling LLP

FDA drug approval packages: NDA 019-501, original, 08/17/1988; NDA 019-501, supplement 003,efficacy-new indication, 08/13/1991; NDA 019-501, supplement 012, efficacy Rx to OTC switch, 02/9/1996; and NDA 021-812, supplement 009, 02/28/2014.

Requester: Elvia O. Gustavson - Jeff Yuen & Associates, Inc.

Kindly provide approved labelling information for ANDA Nos# 209564 and 209611.

Requester: Rama Rao - Rama Rao