Setter: A FOIA Getter

• "I request copies of all documents in the possession of FDA from October 31, 2025 to January 1st 2026 regarding products sold under the brand name "Jamieson"; “Jamieson Wellness”; “Nutricorp”; “Nutrawise”; “Smart Solutions”; “Body Plus”; “Progressive”; “Precision”; “Iron Vegan”; “youtheory” including any a) Form FDA…

Requester: Mitchell Kiernan - Jamieson Laboratories Ltd.

The 483 (as a .pdf) for OXALIS LABS [Baddi / India] located at VILLAGE THEDA, P.O. LODHIMAJRA, TEHSIL - BADDI, SOLAN, HIMACHAL PRADESH 174101, INDIA (IND) for the inspection ending 14-Mar-2025 (FEI 3010868532)

Requester: Jack Antich - Keck Graduate Institute

We respectfully request copies of the following documents: 1. "The 483 (as a .pdf) for Aurobindo Pharma Limited [Patancheru / India] located at UNIT-VI, SY. NO.329/39 & 329/47, CHITKUL VILLAGE, PATANCHERU MANDAL, SANGA REDDY DISTRICT, SANGAREDDY, TELANGANA 502307, INDIA (IND) for the inspection ending 29-Sep-2023 (FEI…

Requester: Aathifa Afrooz Shaik - Keck Graduate Institute

Memos referenced in the ANDA Final Approval Routing Summary for ANDA 208959 dated 10/2/2020 and 1/8/2025 (referenced on the bottom of page 3 of 8).

Requester: Caroline Hoffmann - Odom & Des Roches

Please provide the FDA-483 documents pertaining to Human DRUG Inspection, for the following 4 firms: ARNA Pharma Pty., Ltd., 20 Rodborough, Frenchs Fore, , Australia, (FEI: 3007428662), inspection ending 10/17/2025; BioMed Laboratories, LLC., 8181 Eastpoint D, Dallas, TX, United States, (FEI: 3006784948), inspection e…

Requester: John Schleck - GMP Trends

Please provide the FDA-483 documents pertaining to Human DRUG Inspection, for the following 4 firms: Catalent Pharma Solutions, LLC, 2725 Scherer Dr N, Saint Petersburg, FL, United States, (FEI: 1811396), inspection ending 1/30/2026; Element Materials Technology Oakland-Concord, 2341 Stanwell Dr, Concord, CA, United S…

Requester: John Schleck - GMP Trends

Please provide the FDA-483 documents pertaining to Human DRUG Inspection, for the following 4 firms: Hit Promotional Products Inc., 3320 122nd Ave N, Saint Petersburg, FL, United States, (FEI: 1000352706), inspection ending 1/28/2026; SV Labs Corporation, 480 Airport Blvd, Watsonville, CA, United States, (FEI: 2936586…

Requester: John Schleck - GMP Trends

Please provide the FDA-483 documents pertaining to Human DRUG Inspection, for the following 4 firms: Veranova LP, 2003 Nolte Dr, West Deptford, NJ, United States, (FEI: 2245277), inspection ending 1/23/2026; Lilly del Caribe, Inc, 12.6 Km 65th Infantry Road (Pr01), Carolina, PR, United States, (FEI: 2619243), inspecti…

Requester: John Schleck - GMP Trends

Please provide the FDA-483 documents pertaining to Human DRUG Inspection, for the following 4 firms: Goodier Cosmetics LLC, 9019 Premier Row, Dallas, TX, United States, (FEI: 1611064), inspection ending 1/15/2026; Hood Container Corporation, 300 Forum Pkwy, Rural Hall, NC, United States, (FEI: 3003495738), inspection …

Requester: John Schleck - GMP Trends

All Food and Nutrition Service Supplemental Nutrition Assistance Program violation(s) investigation files for the following entities: My 341 Deli Inc., 341 New Deli Inc., Garden Deli Inc., 341 Green Deli Inc., Brooklyn Mini Market Inc. All Food and Nutrition Service Supplemental Nutrition Assistance Program violation(…

Requester: Alexander White - Valli Kane & Vagnini LLP

FF Request 2015-4081

Requester: CHRISTOPHER KOZAK - MG+M The Law Firm

I am requesting to receive a copy of the 483 inspection report for the location listed below: TRUECARE BIOMEDIX [Balasinor / India] Location: RS#2115,COLLEGE ROAD, BALASINOR, GUJARAT 388255, INDIA (IND) FEI: 3010166683 Inspection End Date: 02/21/2025 Industry: Human Drugs

Requester: Dana Powell - Dana Powell

I am requesting the following information to be provided to me: (i) A scientific definition of gluten; (ii) The symptoms and allergies of someone allergic to gluten; and (iii) A dietary list of gluten-free food products.

Requester: Joshua Blash

Please provide the inspection documents (483, EIR, and 483 response) for the attached records, based on the FEI number and inspection end date. Include any inspection records after the specified end date, if available. Thank you

Requester: Neelima P - Infodesk Inc

Kiniksa Pharmaceuticals is the BLA holder for Arcalyst (rilonacept) BLA 125249, and I am the primary U.S. regulatory contact for this product. The BLA was transferred from Regeneron Pharmaceuticals to Kiniksa in 2021. We have noticed we do not have, and have not been able to obtain, a DDMAC (former OPDP) letter for ad…

Requester: Liza Karpiak - Kiniksa Pharmaceuticals (UK),

Please provide the following inspection-related documents in electronic PDF format: The 483 (in electronic format) for the Human Drugs inspection of following. 1) Patheon Italia S.p.A, located at Via Morolense 5, Ferentino, Italy, inspection ending 02/18/2025 (FEI 3004110157).

Requester: Alpesh Patel - iPharmaSolutions LLC

Please provide the following inspection-related documents in electronic PDF format: The 483 (in electronic format) for the Human Drugs inspection of following. 1) Molclone Labs Private Limited, located at 2/220 Sirumathur Vill, Kundru Medu St, Padappai, India, inspection ending 02/20/2025 (FEI 3011571416).

Requester: Alpesh Patel - iPharmaSolutions LLC

Please provide the following inspection-related documents in electronic PDF format: The 483 (in electronic format) for the Human Drugs inspection of following. 1) Azurity Pharmaceuticals, Inc., located at 841 Woburn St, Wilmington, MA, 01887-3414, USA, inspection ending 02/19/2025 (FEI 3003395329).

Requester: Alpesh Patel - iPharmaSolutions LLC

We respectfully request copies of the following documents: The 483 (as a .pdf) for Guangdong Sunshine Pharmaceutical Co Ltd [Dongguan / China] located at NO. 7, XINXI ROAD, SONGSHANHU HIGH-TECH PARK, DONGGUAN, GUANGDONG 523000, CHINA (CHN) for the inspection ending 18-Apr-2025 (FEI 3026212441)

Requester: Kayser Afram - Keck Graduate Institute

We respectfully request copies of the following documents: The 483 (as a .pdf) for Rubicon Research Limited [Ambarnath Sub-District / India] located at PLOT NO K-30/4 & K30/5, MIDC, ADDITIONAL AMBERNATH AREA, THANE, MAHARASHTRA 421 506, INDIA (IND) for the inspection ending 08-Mar-2024 (FEI 3008252295)

Requester: Wilton Phung - Keck Graduate Institute

We respectfully request copies of the following documents: The 483 (as a .pdf) for Hunan Warrant Chiral Pharmaceutical Co., Ltd. [Changsha / China] located at NO. 139, TONGGUAN AVENUE, TONGGUAN CIRCULAR ECONOMY INDUSTRIAL PARK, WANGCHENG DISTRICT, CHANGSHA, HUNAN 410203, CHINA (CHN) for the inspection ending 14-Nov-20…

Requester: Kayser Afram - Keck Graduate Institute

We respectfully request copies of the following documents: The 483 (as a .pdf) for InfoRLife SA [Brusio / Switzerland] located at CASAI, CAMPASCIO, 7748, SWITZERLAND (CHE) for the inspection ending 03-May-2024 (FEI 3004537783)

Requester: Wilton Phung - Keck Graduate Institute

We respectfully request copies of the following document: The 483 (as a .pdf) for Hubei Gedian Humanwell Pharmaceutical Co., Ltd (Huanggang Site) [Huangzhou / China] located at NO. 1 ZHIQING ROAD, RAILWAY STATION ECONOMIC DEVELOPMENT ZONE, HUANGZHOU DISTRICT, HUANGGANG, HUBEI 438011, CHINA (CHN) for the inspection end…

Requester: Jack Antich - Keck Graduate Institute

FF Request 2025-13673

Requester: Kristen Sellers - FOIA Professional Services

I am submitting this Freedom of Information Act request pursuant to 5 U.S.C. § 552 for records related to the FDA's approval of cyclosporine (also known as cyclosporin A, brand name Sandimmune, manufactured by Sandoz Pharmaceuticals) for clinical use in organ transplantation. Specifically, I am requesting: 1. The orig…

Requester: Hugh Hobbins - Hugh Hobbins

I request copies of the complete administrative case files for the following closed FOIA request submitted to the U.S. Food and Drug Administration: -FOIA Request No. 2013-147 (submitted by Center for Food Safety)

Requester: Juan Vassallo - Investigate Midwest

FF Requests: FDA-FOIA-2023-4254; FDA-FOIA-2023-4255; FDA-FOIA-2023-4277; FDA-FOIA-2023-4461

Requester: Kristen Sellers - FOIA Professional Services

The 483 (in electronic format) for the Office of Pharmaceutical Quality (OPQ)/CDER of Enestia (Sharp), Klöcknerstraat 1, B-3930 Hamont-Achel, Belgium, inspection dates February 18-20, 2026. Thank You!

Requester: Global Key Solutions - Global Key Solutions

The 483 (in electronic format) for the ORA of Takeda Pharmaceuticals, Massachusetts facility, inspection start date December 4, 2025. Thank You!

Requester: Global Key Solutions - Global Key Solutions

Under the Freedom of Information Act, as amended, 5 U.S.C. §§ 552, et seq., COGENCY GLOBAL INC. hereby requests the following: • All documents addressing whether FDA’s listing of Dupixent (dupilumab) from October-December 2024 as having a Potential Signal of a Serious Risk has been marked as “No Action Required” or “N…

Requester: Joanna McCall - COGENCY GLOBAL INC.

We request a log of all FOIA requests that were denied with a 7(a) exemption made in the month of March 2026 including: date, name of requester, full text of request, response of agency to request

Requester: Joe O'Donnell - Canary Data

A description of each request, not just the name of the requester.

Requester: Joe O'Donnell - Canary Data

All form 483s issued for the month of March 2026 including all disposable information contained within each report.

Requester: Joe O'Donnell - Canary Data

FOIA request for information in MS Excel or CSV format for a list of FDA inspections from Jan-2025 as per the attached.

Requester: R. Gulati - Regunalys LLC

Request for list of inspections performed by FDA under the Freedom of Information Act (FOIA) as per the guideline for OCP.

Requester: R. Gulati - Regunalys LLC

Regulatory information is being requested for FDA assessments, under the Freedom of Information Act (FOIA) as per the guideline.

Requester: R. Gulati - Regunalys LLC

Record of the specific drug formulation/description/composition used in the following clinical trials posted, NCT0586152, NCT05636228, NCT06599684, NCT06370039. The molecule described INV-102 has no description, how it is made, from what starting material, chemistry synthesis or biologically derived. The placebo is no…

Requester: Dr. Rocco J Rotello - LECOM school of Osteopathic Medicine

Freedom of Information Act (FOIA) request for FDA inspections and observations listing.

Requester: R. Gulati - Regunalys LLC

Request for list of inspections performed by FDA under the Freedom of Information Act as per the guideline.

Requester: R. Gulati - Regunalys LLC

Please provide the following inspection-related documents in electronic PDF format: The 483 (in electronic format) for the Human Drugs inspection of following. 1) Deepwater Chemicals, Inc, located at 196122 E County Road 40, Woodward, OK, 73801-5656, United States, inspection ending 02/17/2025 (FEI 2013633).

Requester: Alpesh Patel - iPharmaSolutions LLC

I am an investment professional requesting complete FAERS case records for Enjaymo (Recordati), specifically Case IDs 26565686, 26564977, and 26522717. If available, please provide the materials in Excel and PDF format to quinn.lin@sireniacap.com. Thank you!

Requester: Quinn Lin - Sirenia Capital

Please provide the following inspection-related documents in electronic PDF format: The 483 (in electronic format) for the Human Drugs inspection of following. 1) Inventia Healthcare Limited, located at F1- F 1/1, Additional Ambernath Midc, Ambernath (East), Thane, India, inspection ending 02/17/2025 (FEI 3008232264).

Requester: Alpesh Patel - iPharmaSolutions LLC

Please provide the following inspection-related documents in electronic PDF format: The 483 (in electronic format) for the Human Drugs inspection of following. 1) Orchid Pharma Ltd., located at Plots 121-128,128a-133,138-151&159-164, Sidco Industrial Estate, Kanchipuram, India, inspection ending 02/18/2025 (FEI 300374…

Requester: Alpesh Patel - iPharmaSolutions LLC

Please share the Form 483s for the following: 1. Auriga Research Private Limited in Bengaluru, India, FEI: 3019975128, Inspection completed in Feb 2026 2. RK Pharma, Peal River, NY, FEI 3014926340, Inspection completed in March 2026. 3. Lonza Biologics, Inc., Portsmouth, FEI 3001451441. Inspection ended in Feb 2026.

Requester: Bhavish Agarwal - Bhavish Agarwal

I hereby request the Form 483 document in pdf format for the Hubei Biocause Heilen Pharmaceutical Co., Ltd., Jingmen, China, FEI Number: 3007268407. That happen on Nov 14, 2025. Thank You

Requester: Bhavya Mittal

I hereby request the Form 483 document in pdf format for the Microconstants Inc (DBA BioAgilytix Labs, LLC), San Diego, United States, FEI Number: 3007236564. That happen on Mar 03, 2017. Thank You

Requester: Bhavya Mittal

I hereby request the Form 483 document in pdf format for the National Shanghai Center for New Drug Safety Evaluation Ctr, Shanghai, China, FEI Number: 3010719261. That happen on May 22, 2018. Thank You

Requester: Bhavya Mittal

We respectfully request copies of the following documents "The 483 (as a .pdf) for Huiling Pharmaceutical (China) Co., Ltd. [Xiangshan / China] located at NO.6, HUILING ROAD, NATIONAL HEALTH TECHNOLOGY INDUSTRIAL BASE PARK, ZHONGSHAN, 528403, CHINA (CHN) for the inspection ending 22-Aug-2025 (FEI 3009226362)."

Requester: Jamie C Castro - Keck Graduate Institute

We respectfully request copies of the following documents "The 483 (as a .pdf) for Emcure Pharmaceuticals Limited [Sanand / India] located at PLOT NO. SM-14, 15 & 16/1, GIDC, SANAND - II, CHARAL, TAL - SANAND, AHMEDABAD, GUJARAT 382110, INDIA (IND) for the inspection ending 05-Apr-2024 (FEI 3014595023)."

Requester: Jamie C Castro - Keck Graduate Institute

Unredacted Copy of Chemistry Review Summary for DMF 034835

Requester: Fu Jian - Changzhou Pharmaceutical Facto