Setter: A FOIA Getter

calendar records for FDA-CVM employee Charlotte Conway, dates 05.01.25-05.31.25

Requester: Hannah Boudreaux

calendar records for FDA-CVM employee Charlotte Conway, dates 12.01.24-12.31.24

Requester: Hannah Boudreaux

I am writing to request documents pursuant to FOIA involving all regulatory correspondence between the Food & Drug Administration (“FDA”) and Neogen Corporation concerning nitrofurazone and any correspondence or other documents relating to discussions about nitrofurazone, past, current, and proposed regulation rel…

Requester: Haley Hawn - Paul LLP

I am writing to request documents pursuant to FOIA involving all regulatory correspondence between the Food & Drug Administration (“FDA”) and Atlantic Animal Health, Inc. (d/b/a Squire Laboratories, Inc.) concerning nitrofurazone and any correspondence or other documents relating to discussions about nitrofurazone…

Requester: Haley Hawn - Paul LLP

I am writing to request documents pursuant to FOIA involving all regulatory correspondence between the Food & Drug Administration (“FDA”) and Jinan Jinda Pharmaceutical Chemistry Co., Ltd., concerning nitrofurazone and any correspondence or other documents relating to discussions about nitrofurazone, past, current…

Requester: Haley Hawn - Paul LLP

Establishment Inspection report FEI# 3030980560 for inspection conducted in Nov 2024 in Santa Ana, California. Principal Investigator is Dr. Manuchehr Darani

Requester: Gwen Murphy - GSK

I am an investment professional and this is a request under the Freedom of Information Act. We would like to request all FDA form 483 observations related to the Capricor Therapeutics facility for manufacturing deramiocel (CAP-1002) located in San Diego, CA from Jan. 1, 2025 through today.

Requester: Gregory Goulder - ADAR1 Capital Management

Hello,_x000D_ _x000D_ I would like to request the Form 483 issued to Precigen during the 2025 inspection of the manufacturing facility located in Germantown, MD. Thank you.

Requester: Gottesman Norbert - Triple Gate Capital

I would like any correspondence between Biomarin and the FDA regarding TransCon CNP, a product submitted by Ascendis, for the treatment of achondroplasia.

Requester: Gina Domaoal - Boone Capital

Please provide the following inspection-related documents in electronic PDF format:_x000D_ _x000D_ The 483 (in electronic format) for the Medical Devices inspection of Hospi Corporation, located at 1650 S AMPHLETT BLVD STE 201, SAN MATEO, CA, 94402-2529, UNITED STATES, inspection ending 3/14/2025 (FEI 3010761399)._x00…

Requester: Geronimo Baal - 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 Second Pharma Co., Ltd., located at NO 33, WEIWU ROAD HANGZHOU GULF FINE CHEMICAL ZONE, SHANGYU CITY, ZHEJIANG 312369, CHINA (CHN), inspection ending 8/3…

Requester: Geronimo Baal - 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 H & W Molding LLC, located at 4765 CUBA MILLINGTON RD, MILLINGTON, TN, 38053-5411, UNITED STATES, inspection ending 2/06/2025 (FEI 3030244488)._x000D_ …

Requester: Geronimo Baal - Redica Systems

Hello! Please provide an electronic listing (preferably CSV format) of all RRAs conducted since December 10, 2024. If you have any questions, please feel free to reach out. We thank you in advance.

Requester: Geronimo Baal - Redica Systems

Please provide disclosable, redacted 483s 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 processing…

Requester: Geronimo Baal - Redica Systems

Please provide the 483 Responses for the inspections in the attached file. Additional information is provided as a reference for each inspection for clarity. We understand that this request involves complex queue items, and we are willing to wait. Thank you. For questions, please feel free to reach out.

Requester: Geronimo Baal - Redica Systems

Please provide the following inspection-related documents in electronic PDF format: The 483 (in electronic format) for the Medical Devices inspection of HepQuant, LLC, located at 8110 E Union Ave Ste 750, Denver, CO 80237-2969, United States, inspection ending 11/01/2024 (FEI 3011510745). The 483 (in electronic form…

Requester: George Kwiecinski - The Cooper Union

Please provide the following 1 inspection-related document in electronic PDF format: The 483 (in electronic format) for the Medical Devices & Rad Health inspection of Bing Innovations Llc, located in Boca Raton, FL, United States, inspection ending 10/17/2023 (FEI 3008500974).

Requester: George Kwiecinski - The Cooper Union

Please provide the following 1 inspection-related document in electronic PDF format: The 483 (in electronic format) for the Food & Cosmetics inspection of ULTRAtab Laboratories, Inc., located in Highland, NY, United States, inspection ending 2/1/2019 (FEI 3003068822).

Requester: George Kwiecinski - The Cooper Union

Please provide the following 1 inspection-related document in electronic PDF format: The 483 (in electronic format) for the Medical Devices & Rad Health inspection of TAMA Research Corporation, located in Scottsdale, AZ, United States, inspection ending 10/5/2023 (FEI 3009385250).

Requester: George Kwiecinski - The Cooper Union

Please provide the following inspection-related documents in electronic PDF format: The 483 (in electronic format) for the Medical Devices inspection of Dignitana, Inc., located at 10925 Estate Ln Ste W185, Dallas, TX 75238-2315, United States, inspection ending 11/05/2024 (FEI 3012146457). The 483 (in electronic fo…

Requester: George Kwiecinski - The Cooper Union

Please provide the following 1 inspection-related document in electronic PDF format: The 483 (in electronic format) for the Human Drugs inspection of QUAGEN PHARMACEUTICALS LLC, located in West Caldwell, NJ, United States, inspection ending 11/8/2023 (FEI 3012232287).

Requester: George Kwiecinski - The Cooper Union

Please provide the following 1 inspection-related document in electronic PDF format: The 483 (in electronic format) for the Animal Drugs & Feeds inspection of Felix Generics Private Limited, located in Pithampur, Dhar, Madhya Pradesh, India, inspection ending 8/5/2022 (FEI 3014281041).

Requester: George Kwiecinski - The Cooper Union

Please provide the following 1 inspection-related document in electronic PDF format: The 483 (in electronic format) for the Medical Devices & Rad Health inspection of Vacumed, Div of Vacumetrics Inc, located in Ventura, CA, United States, inspection ending 9/13/2023 (FEI 2023529).

Requester: George Kwiecinski - The Cooper Union

Please provide the following 1 inspection-related document in electronic PDF format: The 483 (in electronic format) for the Human Drugs inspection of Arkema Inc., located in Piffard, NY, United States, inspection ending 9/22/2021 (FEI 1314624).

Requester: George Kwiecinski - The Cooper Union

Please provide the following 1 inspection-related document in electronic PDF format: The 483 (in electronic format) for the Food & Cosmetics inspection of Cargill Kitchen Solutions, Inc., located in Lake Odessa, MI, United States, inspection ending 3/4/2021 (FEI 1833311).

Requester: George Kwiecinski - The Cooper Union

Please provide the following 1 inspection-related document in electronic PDF format: The 483 (in electronic format) for the Medical Devices & Rad Health inspection of Somavac Medical Solutions Inc., located in Bartlett, TN, United States, inspection ending 9/22/2023 (FEI 3014827316).

Requester: George Kwiecinski - The Cooper Union

Please provide the following 1 inspection-related document in electronic PDF format: The 483 (in electronic format) for the Biologics inspection of BioLife Plasma Services L.P., located in Grandville, MI, United States, inspection ending 10/17/2019 (FEI 3010960208).

Requester: George Kwiecinski - The Cooper Union

Please provide the following 1 inspection-related document in electronic PDF format: The 483 (in electronic format) for the Biologics inspection of Performance Orthopedics Associates Inc, located in Mountain Brook, AL, United States, inspection ending 2/22/2022 (FEI 3014678321).

Requester: George Kwiecinski - The Cooper Union

Please provide the following 1 inspection-related document in electronic PDF format: The 483 (in electronic format) for the Animal Drugs & Feeds inspection of Piramal Critical Care Inc, located in Bethlehem, PA, United States, inspection ending 9/27/2023 (FEI 1000135935).

Requester: George Kwiecinski - The Cooper Union

Medical device and pharmaceutical product recall data from 01/01/2014 until 12/31/2024. In these data, we are requesting the recalling firm name, the plant FEI, the firm defect awareness date, the firm recall initiation date, the recall classification, the product description, the reason for recall text, the reason fo…

Requester: George Ball - Indiana University

Communications between the FDA and EPA associated with the FDA basing 21 C.F.R. 112.44, as promulgated in 2015, upon EPA's Recreational Water Quality Criteria for E. coli. _x000D_ _x000D_ This request is further described in the Attachment.

Requester: Gary Cohen - Gary Cohen Environmental Firm

Please provide the details of all (disclosed and non-disclosed) inspection records since February 1st, 2025, which includes the following data: FEI Number, Firm Name, Site Address, Inspection ID, Inspection Start Date, Inspection End Date, Classification, Project Area, Product Type, Investigator Name(s), and 483 Issue…

Requester: Future Cures - Future Cures

Please provide all disclosable, redacted inspection records, 483s, 483 responses, and EIRs in electronic format (.pdf) that have been released since February 1st, 2025.

Requester: Future Cures - Future Cures

“I am requesting the name and location of the manufacturer of the active pharmaceutical ingredient (API) used in the recalled product Unisom SleepMinis (Diphenhydramine HCl, 25 mg) associated with FDA recall number D-0362-2025.”

Requester: Frank Beissel - Bell Pharmaceuticals

I am requesting all documents relating to the creation of 1971 regulation \21 CFR § 170.50 Glycine (aminoacetic acid) in food for human consumption\". I am seeking to understand how and why this regulation was made. The regulation cites unspecified animal studies as the only rationale to restrict this amino acid as…

Requester: FOIA-FDA Glycine-1

We have reviewed the FAERS database (from Q4 2012 to Q1 2024) and identified 445 cases of interest. We have selected an additional 12 cases for further review. Would it be possible to provide the following information for these cases (in text format)? Medical history and physical exam findings Endemic mycosis confirma…

Requester: Fariba Donovan - The University of Arizona

Chamberlain purchased Aspide Medical in 2018 along with their 510ks. We are looking for the complete 510k K061445 and the SURGIMESH®WN (K061445) Response to FDA’s Request for Additional Information responses. This response was sent Oct, 2006. The response contained 9 attachments. We have an incomplete submission an…

Requester: F. David Rothkopf - CHAMBERLAIN TECHNOLOGIES, LLC

I am an investment professional and this is a request under the Freedom of Information Act. We request all documents & responses shared by the FDA for the following previous FOIA requests: 2025-3976, 2025-4001, 2025-4005, 2025-4013, 2025-4114, 2025-4118, 2025-4162, 2025-4173, 2025-4184, 2025-4197, 2025-4280, 2025-428…

Requester: ExodusPoint ExodusPoin - ExodusPoint

I am an investment professional and this is a request under the Freedom of Information Act. We are requesting form 483 inspection materials for the inspection conducted on 02/27/2025 for Bausch & Lomb Incorporated, located at Greenville, SC. The FEI number is 1032500 & the inspection ID is 1250877. Thanks!

Requester: ExodusPoint ExodusPoin - ExodusPoint

Please see attached letter that outlines the specific request regarding the FDA CDRH and its PMA and PMA Supplement Process

Requester: Ethan Heck - Ethan Heck

Please see attached letter for description of exact request of information

Requester: Ethan Heck - Ethan Heck

Please see attached letter that outlines all of the information I am reuqesting regarding the Boston Scientific PMA P030017

Requester: Ethan Heck - Ethan Heck

Please see attached letter

Requester: Ethan Heck - Ethan Heck

Status of complaint made on manufacturer Dr. Pepper/7UP for glass that was swallowed from faulty glass bottles.

Requester: Ernest W. Wade Lemasters

We would like the full new drug application (NDA) for semaglutide including Application number N209637, N215256, and N213051.

Requester: Emily Stein - Stanford University

I am seeking all FDA forms 3500; 3500A and 3500B, including all narrative material therein, for the following 12 case IDs, provided in the FAERS public data system. I request that the records be provided by email if possible. Case IDs: 18533582, 18540474, 23852759, 24215184, 24431898, 24445244, 24533162, 24692003, 247…

Requester: Emily Corwin - APM Reports, American Public M

Requesting a copy of FDA 483 and accompanying supportive documentation against Dr. Jorge Amaya (FEI: 3017528735) with an completion date of 11/17/2021 per FDA website.

Requester: Elizabeth Polvent - Arthrosi Therapeutics, Inc.

Please see attached letter outlining the details of request for the disclosable portions of records pertaining to FDA's May 22, 2025, news release regarding illegal e-cigarette seizures with CBP.

Requester: Elizabeth Copeland - Juul Labs Inc.

I submitted a report on May 20 for things happening at Centricity Research in Dublin, OH. I was never contacted back and it’s been a month. At the time I was an employee. I haven’t heard any updates and would like to know what is happening with my case or if there are any changes in status. Even when reaching bac…

Requester: Elijah Gahn - Elijah Gahn

Under the Freedom of Information Act (FOIA), I respectfully request access to all records related to the Biologics License Applications (BLA) for Granulocyte Colony-Stimulating Factor Pegylated Granulocyte Colony-Stimulating Factor (PegGCSF; reference product: Neulasta®). Specifically, we seek: _x000D_ _x000D_ 1) Ori…

Requester: Edric Chang - OcyonBio PR Inc.