Setter: A FOIA Getter
22623 requests collected across all agencies
Please provide the following inspection-related documents in electronic PDF format:_x000D_ _x000D_ The 483 (in electronic format) for the Medical Devices inspection of Angiodynamics Inc. (Navilyst Medical Inc.), located at 8 Glens Falls Tech Park, Glens Falls, NY, 12801-3864, United States, inspection ending 6/25/2021…
Requester: Jonabelle Punzal - 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 Philip Walters Farms, located at 162987 Camp Creek Rd, Wausau, WI, 54403-5846, United States, inspection ending 2/05/2025 (FEI 3034198136)._x000D_ _x000D…
Requester: Jonabelle Punzal - Redica Systems
Please provide the following inspection-related documents in electronic PDF format:_x000D_ _x000D_ The 483 (in electronic format) for the Biologics inspection of Burgwedel Biotech GmbH, located at Im Langen Felde 5, Burgwedel, 30938, Germany, inspection ending 8/29/2023 (FEI 3013514411)._x000D_ _x000D_ - Thank you!
Requester: Jonabelle Punzal - 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 Pedia Parents Inc. DBA Pedia Pals, located at 230 Grider St, Buffalo, NY, 14215-3725, United States, inspection ending 4/24/2025 (FEI 1000122497)._x000…
Requester: Jonabelle Punzal - 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 LSNE-Leon, SLU, D/B/A: PCI Pharma Services, located at Calle Nicostrato Vela (- Pq. Tecnologico León), S/N - M1.1-M1.2, Leon, 24009, Spain, inspection end…
Requester: Jonabelle Punzal - Redica Systems
Please provide the following inspection-related document in electronic PDF format:_x000D_ _x000D_ The 483 (in electronic format) for the Animal Health inspection of JIANGSU TIANHE PHARMACEUTICAL CO., LTD., located at No. 1 Sanjiang Road, Jiangdu Yanjiang Economic Development, Yangzhou, 225200, China, inspection ending…
Requester: Jonabelle Punzal - Redica Systems
Please provide disclosable, redacted 510k 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: Jonabelle Punzal - Redica Systems
Please provide the following inspection-related documents in electronic PDF format:_x000D_ _x000D_ The 483 (in electronic format) for the Biologics inspection of Barr Laboratories Inc., located at 1235 Mays Mill Road, Forest, VA, 24551, United States, inspection ending 5/09/2025 (FEI 3000718267)._x000D_ _x000D_ The 48…
Requester: Jonabelle Punzal - Redica Systems
Please provide the following inspection-related documents in electronic PDF format:_x000D_ _x000D_ The 483 (in electronic format) for the Biologics inspection of MP Biomedicals Asia Pacific Pte Ltd, located at 2 Pioneer Place, MP Biomedicals Headquarters, Singapore, Singapore, inspection ending 3/21/2025 (FEI 30088196…
Requester: Jonabelle Punzal - 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 Fareva Richmond, Inc., located at 2248 Darbytown Road, Henrico, VA, 23231, United States, inspection ending 5/23/2025 (FEI 1120199)._x000D_ _x000D_ The 483…
Requester: Jonabelle Punzal - 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 Sai Life Sciences Limited, located at Unit IV, Plot No. 79A, 79B, 80-A, 80-B, 81-A, 82, Kolhar Industrial Area, Bidar, Karnataka, 585403, India, inspection…
Requester: Jonabelle Punzal - 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 Scientific Protein Laboratories LLC, located at 700 East Main St., Waunakee, WI, 53597, United States, inspection ending 5/02/2025 (FEI 2111173)._x000D_ _x…
Requester: Jonabelle Punzal - 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 Brent Fairchild Livestock, located at 3174 S State Road 103, New Castle, IN, 47362-9697, United States, inspection ending 4/14/2025 (FEI 3036167386)._x00…
Requester: Jonabelle Punzal - 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 DFI Co., Ltd., located at 388-25 Gomo-ro, Jillye-myeon, Gimhae, Korea (The Republic of), inspection ending 1/09/2025 (FEI 3005841640)._x000D_ _x000D_ -…
Requester: Jonabelle Punzal - 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 Naturavit Inc, located at 12328 SW 117th Ct Bldg E, Miami, FL, 33186-3919, United States, inspection ending 1/14/2025 (FEI 3003779775)._x000D_ _x000…
Requester: Jonabelle Punzal - 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 LSNE-Madison, LLC, located at 5501 Research Park Boulevard, Madison, WI, 53719, United States, inspection ending 10/11/2024 (FEI 3011856764)._x000D_ _x000D…
Requester: Jonabelle Punzal - 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 F. B. Indian Ridge Dairy, located at 14750 Highway 16, Energy, TX, 76452-0011, United States, inspection ending 9/18/2023 (FEI 3006172268)._x000D_ _x000D…
Requester: Jonabelle Punzal - Redica Systems
Please provide the following inspection-related document in electronic PDF format:_x000D_ _x000D_ The 483 (in electronic format) for the Medical Devices inspection of Tonica Elektronik A/S, located at LUCERNEMARKEN 15, FARUM, DENMARK, inspection ending 3/27/2025 (FEI 3005545216)._x000D_ _x000D_ - Thank you!
Requester: Jonabelle Punzal - Redica Systems
Please provide the following inspection-related documents in electronic PDF format: The 483 (in electronic format) for the Medical Devices inspection of QED, Inc., located at 750 Enterprise Dr, Lexington, KY, 40510-1030, United States, inspection ending 4/11/2025 (FEI 1037039). The 483 (in electronic format) for the…
Requester: Jonabelle Punzal - Redica Systems
Please provide the following inspection-related documents in electronic PDF format: 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). The 483 (in electr…
Requester: Jonabelle Punzal - Redica Systems
Please provide the following inspection-related documents in electronic PDF format: The 483 (in electronic format) for the Animal Health inspection of Sun Sen Co., Inc., located at 290 COMMERCE CIR, SACRAMENTO, CA 95815-4212, United States, inspection ending 5/24/2023 (FEI 2935829). The 483 (in electronic format) fo…
Requester: Jonabelle Punzal - Redica Systems
Please provide the following inspection-related documents in electronic PDF format: The 483 (in electronic format) for the Animal Health inspection of Ulrich Farms, located at 950 180TH ST, DRESSER, WI 54009-4624, United States, inspection ending 10/21/2021 (FEI 3001184984). The 483 (in electronic format) for the An…
Requester: Jonabelle Punzal - Redica Systems
Please provide the following inspection-related documents in electronic PDF format: The 483 (in electronic format) for the Human Drugs inspection of RARITAN PHARMACEUTICALS INCORPORATED, located at 8 Joanna Ct, East Brunswick, NJ, 08816-2108, United States, inspection ending 4/02/2025 (FEI 3004083931). The 483 (in e…
Requester: Jonabelle Punzal - 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 El Salvador Products Inc., located at 12130 Dairy Ashford Rd, Sugar Land, TX, 77478-6209, United States, inspection ending 6/08/2022 (FEI 3010126598…
Requester: Jonabelle Punzal - Commercial Use
We are requesting the most recent FAERS database results for VYKAT ((diazoxide choline) extended-release tablets). Please send via email.
Requester: Jon Helander - Diadema Partners LP
Requesting complete and unredacted records related to the plasmid DNA backbone sequences used in the manufacture of Pfizer-BioNTech (BNT162b2/COMIRNATY) and Moderna (mRNA-1273/SPIKEVAX) COVID-19 vaccines. This includes: (1) the full nucleotide/genomic sequence of all plasmid DNA backbones used in production, including…
Requester: Jon Fleetwood - JonFleetwood.com
Please provide me with data and communications relating to adverse events reported to the FDA for Hims & Hers Health compounded semaglutide injections between January 1, 2025 and June 17, 2025.
Requester: Jolyon Montague - MBL Capital
Could you please share any communications between the FDA and Bonesupport, Inc since January 1st 2024
Requester: Jolyon Montague - MBL Capital
Could you please share any communications between the FDA and Hims & Hers Health, Inc since January 1st 2024
Requester: Jolyon Montague - MBL Capital
Dear FOIA Officer, Pursuant to the Freedom of Information Act, 5 U.S.C. § 552, I respectfully request the records listed below for the following mobile ultraviolet-C room-disinfection devices, all classified or expected to be classified under Product Code QXJ: Surfacide Helios – Product Code QXJ Tru-D iQ (Tru-D …
Requester: John Flynn - Integrated UVC Solutions LLC
FOIA Request for ANDA Review Documents – ANDA 217022_x000D_ _x000D_ Dear FOIA Officer,_x000D_ _x000D_ Pursuant to the Freedom of Information Act (5 U.S.C. § 552), we respectfully request access to the review documents related to ANDA 217022, which was approved on 12/27/2023, for Esomeprazole Magnesium Delayed-Relea…
Requester: Joe Zhu - YoungTech Pharmaceuticals, Inc
We request a log of all FOIA requests that were denied with a 7(a) exemption made in the month of May 2025 including: date, name of requester, full text of request, response of agency to request
Requester: Joe O'Donnell - Canary Data
A log of all form 483 inspection reports generated by the FDA for the month of May 2025.
Requester: Joe O'Donnell - Canary Data
Any email correspondence between your agency and anyone for the month of May 2025 with the domain name @blueorcacapital.com, @viceroyresearch.com, @muddywaterscapital.com, @scorpioncapital.com, @alderlaneeggs.com, @thebearcave.com, @cablecarcapital.com, @brontecapital.com, @grizzlyreports.com, @bleeckerstreetresearch.…
Requester: Joe O'Donnell - Canary Data
Any email correspondence between your agency and anyone for the month of May 2025 with the surname Aandahl, Perring, Block, Brick, Kahlon, Balik, Cohodes, Eggert, Dorsey, Ma-Weaver, Hempton, Drose, Axler, Lamarco, Wiechert, Adrangi, Quadir, Vagner, Earl, Bonilla.
Requester: Joe O'Donnell - Canary Data
A list of all CDRH petitions received in the past month, including the full text of each submission.
Requester: Joe O'Donnell - Canary Data
A list of all form 483 inspections and their conclusions for the month of May 2025.
Requester: Joe O'Donnell - Canary Data
Please provide copies of all periodic safety assessments made by FDA CVM veterinary safety reviewers pursuant to P&P 1240.3525 for NADAs 141-546 and 141-562. Alternatively, please post them in the CVM FOIA Reading Room, following the precedent set with this one: https://www.fda.gov/media/184483/download?attachment. Th…
Requester: Jodi Ware - Jodi Ware
Copies of BIMO inspection reports for Clinical Investigator/Sponsor Ronald Crystal for inspections conducted: 4/17-4/24, 2002; 4/3-4/5, 2006; 10/16-10/24, 2012. Please include any 483s, establishment inspection reports, responses and correspondences.
Requester: Joanne Spallone - JS GCZp Consulting Services, LLC
Pursuant to the Freedom of Information Act (FOIA), as amended, 5 U.S.C. §§ 552, et seq., COGENCY GLOBAL INC., hereby requests the production of any and all disclosable portions of all documents from November 1, 2021, to February 19, 2025, discussing or otherwise relating to the name and labeling of Motif Foodworks, …
Requester: Joanna McCall - COGENCY GLOBAL INC.
Pursuant to the Freedom of Information Act, 5 U.S.C. § 552, and the implementing regulations under 21 C.F.R. Part 20, we would like to request a copy of FOIA Request Number 2024-2717, including the request letter, the response, and any related correspondence or memoranda._x000D_ This is a commercial request. We agree…
Requester: Joanna McCall - COGENCY GLOBAL INC.
Pursuant to the Freedom of Information Act (FOIA), as amended, 5 U.S.C. §§ 552, et seq., COGENCY GLOBAL INC., hereby requests the agenda for the U.S. Food and Drug Administration’s 13th annual Intergovernmental Working Meeting on Drug Compounding, scheduled for June 4-5, 2025. If material contained in the responsi…
Requester: Joanna McCall - COGENCY GLOBAL INC.
Pursuant to the Freedom of Information Act, 5 U.S.C. § 552, and the implementing regulations under 21 C.F.R. Part 20, we would like to request a copy of FOIA Request Number 2025-3378, including the request letter, the response, and any related correspondence or memoranda._x000D_ This is a commercial request. We agree…
Requester: Joanna McCall - COGENCY GLOBAL INC.
Pursuant to the Freedom of Information Act (FOIA), as amended, 5 U.S.C. §§ 552, et seq., COGENCY GLOBAL INC., hereby requests the production of MedWatch reports and consumer complaints regarding the following Case Numbers:_x000D_ 1. 25057652_x000D_ 2. 25057651_x000D_ 3. 25057650_x000D_ 4. 25057649_x000D_ 5. 25057648…
Requester: Joanna McCall - COGENCY GLOBAL INC.
Pursuant to the Freedom of Information Act (FOIA), as amended, 5 U.S.C. §§ 552, et seq., COGENCY GLOBAL INC., hereby requests the production of MedWatch reports and consumer complaints regarding the following Case Numbers:_x000D_ 1. 25057339_x000D_ 2. 24991885_x000D_ 3. 24984874_x000D_ 4. 24844898_x000D_ 5. 24790898…
Requester: Joanna McCall - COGENCY GLOBAL INC.
All adverse events reported to the FDA Adverse Event Reporting System (FAERS) for CARVYKTI (ciltacabtagene autoleucel) since its approval date (February 28, 2022).
Requester: Jingren Deng - Jingren Deng
All adverse events reported to the FDA Adverse Event Reporting System (FAERS) for Pyrukynd (mitapivat) since its approval date (February 17, 2022).
Requester: Jingren Deng
Under provisions of the Freedom of Information Act, I would like to request a list of all Foreign and Domestic Drug Inspections which were conducted from January 1, 2000 to the present. This list should include CROs (Contract Research Organizations), drug manufacturers, repackers/packers, labelers/relabelers, control …
Requester: Jessica Wade - Clarivate Analytics
_x000D_ I request all FDA-originated or FDA-held records created between 1980 and 2015 that reference:_x000D_ _x000D_ “Dr. Paul Fleissâ€_x000D_ _x000D_ Breastfeeding advocacy or criticism of infant formula_x000D_ _x000D_ Public health dissent regarding raw milk or HIV/AIDS_x000D_ _x000D_ Mentions of Christine Maggi…
Requester: Jesse Fleiss - Jesse Fleiss
All summary files for medical device 510(k) premarket notification applications submitted to the U.S. Food and Drug Administration between June 1, 2025 and June 30, 2025—including but not limited to summaries of safety and effectiveness, decision memoranda, clearance letters, summaries of administrative review, and …
Requester: Jeremy Hennessy - Pharm3r