Setter: A FOIA Getter

I request a copy of the 483 associated with the facility below. _x000D_ _x000D_ Approval is $75.00._x000D_ _x000D_ Inspection Date Range is 1-15-2023 through 2-15-2023_x000D_ _x000D_ Alexion Pharma International Operations Limited [Dublin / Ireland], Address: COLLEGE BUSINESS AND TECHNOLOGY PARK, DUBLIN, D15 R925, IRE…

Requester: Dana Powell - Dana Powell

All correspondence (and any attachments to those correspondence) between (1) the Food and Drug Administration (“FDA”) and (2) Concert Pharmaceuticals, Inc. and/or Sun Pharmaceutical Industries, Inc. (collectively, “Concert/Sun”) related to or concerning the FDA’s Breakthrough Therapy Designation (“BTD”) …

Requester: Dan Roland - Finnegan, Henderson, Farabow,

We are requesting Summary Basis of Information of NDA #019962 viz., Medical Reviews, Chemistry reviews, Pharmacology Reviews, Statistical Reviews, Non-Clinical Reviews, Clinical Pharmacology Biopharmaceutics reviews, Risk Assessment and mitigation reviews, Summary Review, Cross discipline team leader review, Administr…

Requester: Daliya Bharati - Rubicon Research Limited

All records related to the MQSA certification for the facility called Sunset Radiology, Inc. located at 7000 S.W. 97th Ave, Ste 117, Miami, Florida 33173, including all applications for certification as well as all documents submitted to establish recertification.

Requester: Cosme Caballero - Deutsch Blumberg & Caballero,

Most recent approved labeling for NDA 019976

Requester: Cortni Thill-Mathison - Padagis

Seeking redacted FDA GLP inspection report for Prolytix (fka Haematologic Technologies). Request for inspection was through the MHRA, UK.

Requester: Corrina Anne Roman Kreuze - Corrina Kreuze

I hereby request all adverse drug events for the drug Ayvakit, within the date range provided, inclusive, where the indication was ISM. I would like these both in PDF and XLSX format.

Requester: Cornel Duhaney - Lazro, Benton, Hask LLC

VAERS Report

Requester: Conway Homer

Facility: Gordon Schanzlin New Vision Institute (Formerly Gordon Binder Vision Institute, Location: 4130 La Jolla Village Drive, Suite 300, La Jolla, CA 92037 (formerly located at 8910 University Center Lane, Suite 800, San Diego, CA 92122). FEI Number: 1000220853 Inspection Timeframe: 20MAR2003 - 1APR2003 (03/20/200…

Requester: Conner Kidd - Gordon Schanzlin New Vision In

Dear FDA FOIA Representatives,_x000D_ I am writing to request access to public records under the freedom of information act_x000D_ (FOIA) and the Iowa Open Records Law. Specifically, I am seeking communications_x000D_ exchanged between the U. S. Food and Drug Administration (FDA)and the Iowa_x000D_ Attorney General’…

Requester: Colette Noble

Good afternoon, I am in request of a certified copy of the attached FOIA production pertaining to request # 2025-2631 dated 3/21/2025. If you have any questions, please email cmhue@vorys.com or call my direct line at 513-723-4013. Thank you!

Requester: Colette Hue - Vorys, Sater, Seymour and Peas

Closed

Requester: Closed

Dear Division of Freedom of Information Team,_x000D_ _x000D_ We respectfully request all entry-line records that contain any of the following data points in reference to any entry-line’s FSVP Importer, Importer of Record, or Consignee; for entry-lines with submission or arrival dates from May 01, 2025, to May 31, 20…

Requester: Claudio Innocenti - United Safety Agents

Rockline would like a copy of the latest FDA inspection report for CIP4 Srl via Mario Idiomi 6, Assago, Milano Italy, 25007. DUNS# 429079957 EST# 3010866875.

Requester: Cindy Waning - Rockline Industries

I am requesting an enhanced copy of the May 2025 FDA FOIA closed log. Please include the “Status” column that was present in the April 2025 closed log but is missing from the May version.

Requester: Christopher Womack - FOIA Document Source

Approval Routing Summary for ANDA # 213680 (Biocon)

Requester: Christopher Womack - FOIA Document Source

All available documents related to 510k #K242610

Requester: Christopher Womack - FOIA Document Source

We are requesting the Form 483 inspection reports for the following businesses located at the associated addresses for inspections on or about the associated date: 1. Allergan Pharmaceuticals Ireland [Westport / Ireland] Address: CARROWBEG CASTLEBAR ROAD, WESTPORT, IRELAND (IRL) FEI: 3002806285 Inspection End Date…

Requester: Christopher Womack - FOIA Document Source

Please provide all releasable documents from FDA FOIA Log numbers: 2022-1296, 2019-7199

Requester: Christopher Womack - FOIA Document Source

All releasable documents from log # 2025-2777, delivered in electronic format.

Requester: Christopher Womack - FOIA Document Source

Approval Routing Summary for ANDA # 213719 (Zydus)

Requester: Christopher Womack - FOIA Document Source

I am requesting all available inspection records (redacted) for the following inspection:_x000D_ Mylan Technologies, Inc,_x000D_ 110 Lake St_x000D_ Saint Albans, VT 05478-2266_x000D_ FEI Number: 1220747_x000D_ Inspection End Date: 12/18/2023_x000D_ Human Drugs_x000D_

Requester: Christopher W. McGorman

Any and all records pertaining to FDA Trade Complaint No.: COR19000161.

Requester: Christopher Cocchiaraley

FOI(Freedom of Information) Summary for Auero S 700 G NADA# 035-805. This product is now owned by PAHC as a result of a purchase from Zoetis

Requester: Christen Libertiny - Phibro Animal health Corporati

GORE-TEX Vascular Grafts

Requester: Chris Pritchard - Chris Pritchard

Records and communications about Teva Pharmaceuticals USA, Inc. and its subsidiaries’ manufacturing of generic valsartan and generic metformin. Specifically, I am requesting:_x000D_ _x000D_ 1. Records and communications produced or received by FDA personnel between January 1, 2022, and present that relate to:_x000D_…

Requester: Chris Nelson - Judicial Watch, Inc.

Stason Pharmaceuticals, Inc. currently owns NDA 009053 for Purinethol (Mercaptopurine Tablets) which was originally approved on 09/11/1953. However, we have not received any copies of clinical study data for this drug. This request is to obtain unredacted copies of clinical study data submitted in Module 5 and Module …

Requester: Chris Alwood - Stason Pharmaceuticals

Sun Pharma's Halol facility was inspected in June-25 and received 8 observations. Request for access to the Form 483

Requester: charul agrawal - BofA Securities India Limited

Requesting for personal research the following:_x000D_ Number of 501(k), PMA, and De Novo clinical trials applications that were submitted to the FDA.

Requester: Charles Griffin - Charles Griffin

The Applicant “Itaan Pharma INC” requests that the Agency to provide physicochemical data for two lots of the Reference Listed Drug (RLD) product of Midazolam in 0.8% Sodium Chloride Injection, USP 50 mg/50 mL (NDA# 215868, held by Exela Pharma Sciences LLC). This request is being made for the purpose of the ANDA …

Requester: Chandu Kankanala - ITAAN PHARMA INC

A copy of the CMC section of the original ANDA for ANDA 072429, Fenoprofen Calcium Tablets, 600 mg held by Strides Pharma Global Pte Ltd which was approved on August 17, 1988.

Requester: Chandran Tiruvattar - Strides Pharma Inc.

I am requesting a copy of my own organization unredacted Establishment Inspection Report (EIR). The Inspection was performed on August 27, 2024, and a copy of the Form 483 is attached with this request. Organization Name: Medical Instrument Development Laboratories, Inc. (dba MID Labs) Facility Location/Address: 557…

Requester: Chan Lee - Medical Instrument Development

I request the following three Office of Surveillance and Epidemiology Reviews associated with these products and safety signals: 1005162: Semaglutide, Aspiration (PT) 1004527: GLP-1 Analogues, Gallbladder related disorders (SMQ) 1004498: GLP-1 Analogues, Acute kidney injury (PT)

Requester: Chad Terhune - Reuters News

FDA EIR Narrative portion for the following clinical investigator site inspections._x000D_ _x000D_ Stephanie B. Rutrick, FEI 3034528616, Inspection 1262237, End Date 02/13/2025_x000D_ Alexander J. White, FEI 3034528605, Inspection 1262701, End Date 02/21/2025_x000D_ Brandon K. Lenox, FEI 3034528062, End Date 02/27/202…

Requester: Chad Belschner - Eli Lilly & Company

Form 483 issued to Samsung Biologics Co., Ltd. (FEI: 3010479596) Site address: 300, Songdobio-daero, Yeonsu-gu, Incheon, 21987, Republic of Korea. Inspection Date: May 19, 2025 - May 27, 2025. CELLTRION would like to confirm the details specifically for the product area of 'drugs'.

Requester: CELLTRION CELLTRIO - Celltrion, INC.

I am requesting on behalf of my company our Establishment Inspection Report for the routine inspection carried out October 30, 2017 through November 2, 2017 at ARC Medical Supplies located here in Miyun China. EIR OP ID 67014 for fiscal year 2018 fiscal. We never received our EIR.

Requester: Cathy Zhao - ARC Medical Supplies

EIR reports, 483 reports, warning letters and notices of non compliance arising from FDA inspection activity at Rocky Mountain Lions Eye Bank, Colorado.

Requester: CATHERINE REILLY - MEDICAL INDEPENDENT

Dear Sir or Madam:_x000D_ _x000D_ Pursuant to the Freedom of Information Act (FOIA), 5 U.S.C. § 552, I previously submitted a FOIA request (Confirmation Number: FDA25113590) for the Establishment Inspection Report (EIR) for Nephron SC, LLC, FEI #3010892830, located at 4500 12th Street Ext., West Columbia, SC, based o…

Requester: Caroline Hansen - Nephron SC, LLC

Communications between N8 Medical, Dr. Shawn Langer, and CDRH and OCP regarding the Cerashield Endotracheal Tube

Requester: Carl Genberg

Kindly produce the Form 483 Observations, FDA Inspection Report, inspection records, or any recorded deviations from regulation noted within the course of routine inspections conducted by FDA personnel at the below facility on the below dates._x000D_ _x000D_ Jiangsu Caina Medical Co., Ltd._x000D_ FEI No.: 3005670221_x…

Requester: Carina Landgraf - Carina Landgraf

Kindly produce the Form 483 Observations, FDA Inspection Report, inspection records, or any recorded deviations from regulation noted within the course of routine inspections conducted by FDA personnel at the below facility on the below dates._x000D_ _x000D_ Shanghai Kindly Enterprise Development Group Co., Ltd._x000D…

Requester: Carina Landgraf - Carina Landgraf

I requesting a copy of the 483 associated with the facility below:_x000D_ _x000D_ GenIbet Biopharmaceuticals [Oeiras / Portugal], Address: AVENIDA DA REPÚBLICA, EDIFÍCIO DA INSTALAÇÃO PILOTO DO IBET, OEIRAS, 2780-157, PORTUGAL (PRT), FEI: 3011160795, Inspection End Date: 2025-01-21, Biologics, Human Drugs_x000D_ _…

Requester: Caitlin Crawford - Caitlin Crawford

I request all Form 483’s issued to Wacker Biotech GmbH, in Thuringia 07745, Germany (DEU) between 1/1/20-present day. The FEIN is 3002808427. If no Form 483’s were issued, can you please confirm if an inspection has occurred in that time frame but no 483’s were issued, or if no inspection has occurred?

Requester: Caitlin Crawford - Caitlin Crawford

I request a copy of the 483 report for the facility below. The dates for the search are: 1-20-2023-2/1/2023:_x000D_ _x000D_ Alexion Pharma International Operations Limited [Dublin / Ireland], Address: COLLEGE BUSINESS AND TECHNOLOGY PARK, DUBLIN, D15 R925, IRELAND (IRL), FEI: 3012889718, Inspection End Date: 2023-01-2…

Requester: Caitlin Crawford - Caitlin Crawford

Requesting a copy of the 483 inspection report for the following:_x000D_ _x000D_ Roche Diagnostics GmbH [Penzberg / Germany], Address: NONNENWALD 2, PENZBERG, D-82377, GERMANY (DEU), FEI: 3002806560, Inspection End Date: 2023-03-10, Biologics, Human Drugs_x000D_ _x000D_ Date Range: 3-10-2023-3-15-2023

Requester: Caitlin Crawford - Caitlin Crawford

I request a copy of all Form 483’s issued to Vetter Development Services Usa Inc., in Skokie, Illinois, USA from 1/1/20-present. The FEIN is 3008406517. If no Form 483’s were issued, can you please confirm if an inspection has occurred in that time frame but no 483’s were issued, or if no inspection has occurr…

Requester: Caitlin Crawford - Caitlin Crawford

I request a copy of all Form 483’s issued to Wacker Biotech GmbH, in Saxony-Anhalt 06120, Germany (DEU) from 1/1/20-5/28/2025. The FEIN is 3008840280. If no Form 483’s were issued, can you please confirm if an inspection has occurred in that time frame but no 483’s were issued, or if no inspection has occurred?

Requester: Caitlin Crawford - Caitlin Crawford

Requesting 2 validated analytical methods (full method and validation report) used for fenbendazole residue studies in cattle for NADA 128-620, Panacur 10% oral suspension for beef and dairy cattle:_x000D_ _x000D_ 1. Cattle Liver marker residue analytical method for parent fenbendazole Approved on 2 Sept 1983. An esta…

Requester: Cait Brennan - Chanelle Pharmaceuticals Manuf

Please provide the documentation for the De Novo request for: DEN240045 Trade/Device Name: Teal Wand Regulation Number: 21 CFR 866.2920 Regulation Name: Device for home collection and transportation of clinical specimens by lay users for infectious disease testing Regulatory Class: Class II Product Code: SEP D…

Requester: Brynn Stanley - Gardner Law

On the afternoon of May 8, 2025 at 2:17pm, I submitted an adverse reaction complaint to the FDA, concerning Rold Gold pretzels that my child ate and reacted to. The Individual Case Safety Report Number (ICSR) is 2176406. The FDA said it would hinder the investigation to share information with me but going through Free…

Requester: Brittni Fleenor