Setter: A FOIA Getter
22623 requests collected across all agencies
Please provide the MedWatch for following case IDs: 26401590, 26356880, 26477636, 26377101,26354720, 26350681,26233121, 25957118, 25706390
Requester: Rushi Purohit - Ascendis Pharma
This is a request under the Freedom of Information Act. I am requesting copies of the redacted FDA Adverse Event Reporting System (FAERS) individual case safety reports, including redacted narratives, for the following FAERS Case IDs: 26463026 26387858 26339507 The suspect product associated with these cases is Vueway…
Requester: Thomas Aquilina - GE Healthcare
We are requesting Visitor Logs for the FDA White Oak Campus located at 10903 New Hampshire Ave, Silver Spring, MD 20993, for the month of March, 2026.
Requester: Isabella Pietro - PoliScio Analytics
I am requesting full case write-ups for CASE ID 26560896 for suspect product VOYXACT CASE ID 26554981 for suspect product CRENESSITY
Requester: Jon Helander - Diadema Partners
Good Day, We kindly request all disclosable, redacted 483Rs in electronic format (.pdf) that have been released since March 1st, 2026. Please exclude any documents previously shared with Redica Systems. If any questions or issues arise before or during processing, please feel free to contact us at records@redica.com. …
Requester: Joshua Boloy - Redica Systems
Good Day, We kindly request all disclosable, redacted 510Ks in electronic format (.pdf) that have been released since March 1st, 2026. Please exclude any documents previously shared with Redica Systems. If any questions or issues arise before or during processing, please feel free to contact us at records@redica.com. …
Requester: Joshua Boloy - Redica Systems
Good Day, We kindly request all disclosable, redacted EIRs in electronic format (.pdf) that have been released since March 1st, 2026. Please exclude any documents previously shared with Redica Systems. If any questions or issues arise before or during processing, please feel free to contact us at records@redica.com. T…
Requester: Joshua Boloy - Redica Systems
Good Day, We kindly request all disclosable, redacted 483s in electronic format (.pdf) that have been released since March 1st, 2026. Please exclude any documents previously shared with Redica Systems. If any questions or issues arise before or during processing, please feel free to contact us at records@redica.com. T…
Requester: Joshua Boloy - Redica Systems
Gentlemen: I write to request, under the Freedom of Information Act, the FDA Medical Device Division and any other appropriate division of the FDA governing medical devices and their manufacturers, marketers and sellers, that all documents be produced having to do with Medtronic, Inc’s. or Medtronic, plc’s Capsurefix …
Requester: Caleb Boone
Dear Sir/Madam, I would like to request Tentative Approval letter of Nintedanib Capsule for the below Applicants - 1. GLENMARK PHARMS LTD, ANDA – 212555. TA letter issued on 03/26/2026. 2. QILU PHARMACEUTICAL CO., LTD, ANDA – 219708. TA letter issued on 03/17/2026. 3. TEVA PHARMACEUTICALS DEVELOPMENT INC, ANDA – 21937…
Requester: Komal Patel - Dr. Reddy's Laboratories Inc.
I am requesting to receive the summary case reports for the following case ID from the AEMS system: 26554981
Requester: Kristen Sellers - FOIA Professional Services
A log of inspections conducted and / or tracked by the FDA and / or a state or state contractor that resulted in a form 483 inspection report or state equivalent for the month of March, 2026, including operation date, firm name, FEI number, facility address, center and product area.
Requester: Mike Williams - The Capitol Forum
Please provide the Complete Response Letter received April 18, 2025 for EYLEA HD (BLA 761355).
Requester: Brian Janelsins - Boehringer Ingelheim Pharmaceu
Please provide the product quality (chemistry) reviews for supplement 117 (approved March 20, 2018) for LUCENTIS (BLA 125156), the original BLA (approved August 23, 2024) for PAVBLU (BLA 761298), the original BLA (approved August 09, 2024) for ENZEEVU (BLA 761382), supplement 60 (approved August 12, 2019) for EYLEA (B…
Requester: Brian Janelsins - Boehringer Ingelheim Pharmaceu
Please provide the following inspection-related documents in electronic PDF format: The 483 (in electronic format) for the Human Drugs inspection of following. 1) Sinsin Pharmaceutical Co., Ltd., located at 9 Sojeongsandandong-Ro, Sojeong-Myeon, Sejong, Korea (the Republic of), inspection ending 02/14/2025 (FEI 300227…
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) Zhuhai Rundu Pharmaceutical Co Ltd, located at No 6 North Airport Road, Jinwan, Zhuhai, China, inspection ending 02/17/2025 (FEI 3009954717).
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) Nordmark Pharma GmbH, Pinnauallee 4, Uetersen, Germany, inspection ending 02/13/2025 (FEI 3003293533).
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) Abhilasha Pharma Private Ltd, located at 1409 Plot No 1408, Gidc Naka, Anklesvar, India, inspection ending 02/07/2025 (FEI 3010079586)
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) Pillar5 Pharma Inc., located at 365 Madawaska Blvd, Arnprior, Canada, inspection ending 02/07/2025 (FEI 3000241849)
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) Resonance Laboratories Private Limited, located at 8c Kiadb Industrial Area, & 9a, Doddaballapur, India, inspection ending 02/07/2025 (FEI 3004483648)
Requester: Alpesh Patel - iPharmaSolutions LLC
Request for released records.
Requester: Sonika Shinghal - Sovish
Please share the Form 483 for Janssen Cilag Manufacturing LLC. Inspection details: • End Date: Feb 11, 2026 • Site: Janssen Cilag Manufacturing LLC, Gurabo, United States • FEI Number: 3006244497
Requester: Sonika Shinghal - Sovish
The 483 (as a .pdf) for CSL Behring GmbH [Marburg / Germany] located at EMIL VON BEHRING STRASSE 76, MARBURG, HESSE 35041, GERMANY (DEU) for the inspection ending 18-Apr-2024 (FEI 3003098680)
Requester: Andrew Trejo - Keck Graduate Institute
Please share the Form 483 for Lilly del Caribe, Inc. Inspection details: • End Date: Jan 30, 2026 • Site: Lilly del Caribe, Inc, Carolina, United States • FEI Number: 2619243
Requester: Sonika Shinghal - Sovish
I am requesting the most current labels for BLA 125320. This BLA contains two approved drug names, PROLIA and XGEVA, and the request is for both drugs. Please provide all levels of labeling: package insert, medication guide, instructions for use, container, blisters, and carton labels for each product as applicable. T…
Requester: Jose Nieves - Meitheal Pharmaceuticals
The 483 (as a .pdf) for Synexa Life Sciences [Cape Town / South Africa] located at 4 KUNENE CIRCLE, CAPE TOWN, SOUTH AFRICA for the inspection ending 06-Sep-2024 (FEI 3009574937)
Requester: Ruswel Domingo - Keck Graduate Institute
The 483 (as a .pdf) for Prof. Bernardo Leon Rapoport [Johannesburg / South Africa] located at 129 OXFORD ROAD, JOHANNESBURG, SOUTH AFRICA for the inspection ending 29-Jan-2026 (FEI 3021927419)
Requester: Ruswel Domingo - Keck Graduate Institute
Copies of any U.S. Food and Drug Administration (FDA) memoranda regarding setting the current Cumulative Estimated Daily Intake (CEDI) value for Nylon MXD-6 (CAS Reg. No. 25718-70-1)
Requester: Anne-Catherine Barrett - Steptoe LLP
The dossiers for any GRAS notices submitted by or on behalf of Standing Ovation, as well as any e-mails between FDA and the notifier
Requester: Josh Kittleson - New Culture
To Whom it May Concern: As permitted by the Freedom of Information Act (FOIA), I am hereby requesting the following document: Form FDA 483: The Medicine Shoppe Pharmacy, Walfer Corporation dba Wallace Pharmacy Florida United States End Dates of inspection: 16 Mar 2020 FEI: 3016458098 Project Area: Drug Quality Assuran…
Requester: Pravallika Pravallik - Clarivate Analytics
To Whom it May Concern: As permitted by the Freedom of Information Act (FOIA), I am hereby requesting the following document: Form FDA 483: Light Age, Inc. New Jersey United States End Dates of inspection: 11 Mar 2020 FEI: 2246844 Project Area: Compliance: Devices Classification: OAI I confirm that Clarivate Analytics…
Requester: Pravallika Pravallik - Clarivate Analytics
To Whom it May Concern: As permitted by the Freedom of Information Act (FOIA), I am hereby requesting the following document: Form FDA 483: Maitland Labs of Central Florid. Florida United States End Dates of inspection: 28 Feb 2020 FEI: 3013854204 Project Area: Drug Quality Assurance Classification: OAI I confirm that…
Requester: Pravallika Pravallik - Clarivate Analytics
Please provide a digital copy of the FDA Form 483 issued to Fresenius USA Manufacturing, Inc. following the FDA inspection conducted on March 6, 2026, by the Denver District Office at 475 W 13th St, Ogden, Utah (FEI Number 1713747). The commodity listed for the inspection is Human Drugs.
Requester: Isabella Pietro - PoliScio Research
To Whom it May Concern: As permitted by the Freedom of Information Act (FOIA), I am hereby requesting the following document: Form FDA 483: Pharma Nobis LLC/ Humco Holding Group, Inc Texas United States End Dates of inspection: 13 Mar 2020 FEI: 1611206 Project Area: Drug Quality Assurance Classification: OAI I confirm…
Requester: Pravallika Pravallik - Clarivate Analytics
To Whom it May Concern: As permitted by the Freedom of Information Act (FOIA), I am hereby requesting the following document: Form FDA 483: Unipack LLC New Jersey United States End Dates of inspection: 16 Oct 2020 FEI: 3008275696 Project Area: Drug Quality Assurance Classification: OAI I confirm that Clarivate Analyti…
Requester: Pravallika Pravallik - Clarivate Analytics
To Whom it May Concern: As permitted by the Freedom of Information Act (FOIA), I am hereby requesting the following document: Form FDA 483: KDunn and Associates, P.A. dba HealthQuilt Texas United States End Dates of inspection: 13 Aug 2020 FEI: 3017159096 Project Area: Bioresearch Monitoring Classification: OAI I conf…
Requester: Pravallika Pravallik - Clarivate Analytics
To Whom it May Concern: As permitted by the Freedom of Information Act (FOIA), I am hereby requesting the following document: Form FDA 483: Sharp Sterile Manufacturing, LLC Massachusetts United States End Dates of inspection: 27 Oct 2020 FEI: 3012144557 Project Area: Drug Quality Assurance Classification: OAI I confir…
Requester: Pravallika Pravallik - Clarivate Analytics
To Whom it May Concern: As permitted by the Freedom of Information Act (FOIA), I am hereby requesting the following document: Form FDA 483: Medical Center Pharmacy, Inc. Tennessee United States End Dates of inspection: 09 Apr 2020 FEI: 3010536120 Project Area: Drug Quality Assurance Classification: OAI I confirm that …
Requester: Pravallika Pravallik - Clarivate Analytics
To Whom it May Concern: As permitted by the Freedom of Information Act (FOIA), I am hereby requesting the following document: Form FDA 483: MasterPharm LLC New York United States End Dates of inspection: 15 Jun 2020 FEI: 3005734706 Project Area: Drug Quality Assurance Classification: OAI I confirm that Clarivate Analy…
Requester: Pravallika Pravallik - Clarivate Analytics
We are requesting case reports on the specified case numbers on toxicities/adverse effects associated with administration of Pluvicto (lutetium Lu 177 vipivotide tetraxetan). This request is via the Freedom of Information Act. The reason for the request is for academic purposes. As per our previous communication, we h…
Requester: John Villano, MD, PhD - University of Kentucky Markey
To Whom it May Concern: As permitted by the Freedom of Information Act (FOIA), I am hereby requesting the following document: Form FDA 483: Catalent Pharma Solutions LLC North Carolina United States End Dates of inspection: 28 Sep 2020 FEI: 1000110912 Project Area: Drug Quality Assurance Classification: OAI I confirm …
Requester: Pravallika Pravallik - Clarivate Analytics
To Whom it May Concern: As permitted by the Freedom of Information Act (FOIA), I am hereby requesting the following document: Form FDA 483: Neil Sheth, MD Arizona United States End Dates of inspection: 24 Nov 2020 FEI: 3017517342 Project Area: Bioresearch Monitoring Classification: OAI I confirm that Clarivate Analyti…
Requester: Pravallika Pravallik - Clarivate Analytics
To Whom it May Concern: As permitted by the Freedom of Information Act (FOIA), I am hereby requesting the following document: Form FDA 483: Yangzhou H&R Plastic Daily Chemical Co., Ltd. Yangzhou China End Dates of inspection: 24 Oct 2025 FEI: 3014543859 Project Area: Drug Quality Assurance Classification: OAI I confir…
Requester: Pravallika Pravallik - Clarivate Analytics
To Whom it May Concern: As permitted by the Freedom of Information Act (FOIA), I am hereby requesting the following document: Form FDA 483: China Pharmaceutical University. Nanjing China End Dates of inspection: 20 Sep 2024 FEI: 3009350497 Project Area: Drug Quality Assurance Classification: OAI I confirm that Clariva…
Requester: Pravallika Pravallik - Clarivate Analytics
To Whom it May Concern: As permitted by the Freedom of Information Act (FOIA), I am hereby requesting the following document: Form FDA 483: SMS Pharmaceutical Limited - Unit VII Andhra Pradesh India End Dates of inspection: 12 Dec 2025 FEI: 3008654585 Project Area: Drug Quality Assurance Classification: OAI I confirm …
Requester: Pravallika Pravallik - Clarivate Analytics
A copy of the March 17, 2026 letter tentatively approving ANDA 219708 for Nintedanib Capsules.
Requester: Aisha Evans - Hyman, Phelps & McNamara, P.C.
A copy of the March 26, 2026 letter tentatively approving ANDA 212555 for Nintedanib Capsules.
Requester: Aisha Evans - Hyman, Phelps & McNamara, P.C.
A copy of the March 26, 2026 letter tentatively approving ANDA 219371 for Nintedanib Capsules.
Requester: Aisha Evans - Hyman, Phelps & McNamara, P.C.
FOIA Request for Establishment Inspection Report (EIR) – BSO LLC (FEI 3030548360) Facility Name: BSO LLC Address: 741 Corporate Circle, Ste A–H, Golden, Colorado 80401 FEI Number: 3030548360 I am specifically requesting the following FDA inspection records: - Establishment Inspection Report (EIR) Inspection End Date: …
Requester: Greg Rockers - BSO LLC
Dear FOIA Officer, I hope you are doing well. Pursuant to the Freedom of Information Act (FOIA), we hereby request access to and copies of the diluent labeling associated with the Reference Listed Drug (RLD) Geref under NDA 020443, for all approved strengths. Specifically, we request - Diluent container labels (vial/a…
Requester: Bapi Reddy Eemana - BPI Labs, LLC