Setter: A FOIA Getter

Hello, I am requesting the EIR and 483 for the following Medical Device inspection: Sterilmed, Inc. 5010 Cheshire Pkwy N Ste 2 Plymouth, MN 55446-4101 FEI #: 3011276773 Inspection End Date 05/22/2024 Inspection ID: 1234341 Inspection Type: Medical Devices Maximum cost allowed is $300.00. Electronic copies are preferre…

Requester: Lex J. Pearce - Jabil Inc.

Captek Softgel International, Inc.- 16218 Arthur St., Cerritos, CA 90703 - 2710 Progress Street Vista, CA 92081 - Freedom of Information Act (FOIA) request

Requester: Jackie Reyna - Life Extension

Please share teh Form 483 for Pan-African Food Distributors Inc.. Inspection details: • End Date: Jun 04, 2025 • Site: Pan-African Food Distributors Inc., Louisville, United States • FEI Number: 3014768435 CategryL Foods and Cosmetics

Requester: Sonika Shinghal - Sovish

Good Day! Based on the inspections listing we requested and received from the FDA, kindly please provide the following inspection-related documents in electronic PDF Format: The 483 (in electronic format) for the Biologics inspection of CSL Plasma Inc., located at 3302 Walters Ln, District Heights, MD 20747-5101 Unite…

Requester: Joshua Boloy - Redica Systems

Good Day! Based on the inspections listing we requested and received from the FDA, kindly please provide the following inspection-related documents in electronic PDF Format: The 483 (in electronic format) for the Biologics inspection of Rejuvenating Fertility Center, located at 315 W 57th St Ste 309, New York, NY 1001…

Requester: Joshua Boloy - Redica Systems

In FDA FOIA 2026-389 we asked FDA to provide all data and documentation FDA sourced to make the following benefit claim to pets found in the Federal Register (Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals - under Costs and Benefits): The total annualized …

Requester: Susan Thixton

We request any/all nexus FDA investigations, reports, documented violations related to the city, person, llc, non-profit, or organization affiliated in a complaint or identyfing by use of the word PARDEEVILLE in their name or used in any FDA compliant.

Requester: Chris Ederesinghe - Voden Investigations LLC

Our office represents Thomas Dayon and Andrea Dayon regarding personal injuries Thomas Dayon sustained on or about January 23, 2024, when he took Neptune's fix (manufactured by Neptune Resources, LLC) which contains Tianeptine. I have enclosed a copy of the executed Retainer Agreement we have with Mr. and Mrs. Dayon. …

Requester: Timothy E. Dinan, Esq. - Laddey, Clark & Ryan, LLP

Good Day! Based on the inspections listing we requested and received from the FDA, kindly please provide the following inspection-related documents in electronic PDF Format: The 483 (in electronic format) for the Medical Devices inspection of Excel Medical Electronics LLC, located at 7111 Fairway DR STE 205, Palm Bch …

Requester: Joshua Boloy - Redica Systems

Dear Officer, Pursuant to the Freedom of Information Act, please provide the following inspection-related documents in electronic PDF format: The Establishment Inspection Report (EIR) for the Drug Quality Assurance inspection of Morton Salt Inc, located at 151 Industrial Ave, Rittman, Ohio, 44270, United States, inspe…

Requester: Sebastien Geoffroy - ICU Medical Canada Inc.

My inquiry is regarding any mechanism(s) that is/are capable of remotely affecting an object, including the human body. To elaborate: for over two years, I’ve been experiencing unexplained sensations of being touched by something out of the quantum field. Sometimes these sensations are as subtle as a simple touch, and…

Requester: Chris Butler

Good Day! Based on the inspections listing we requested and received from the FDA, kindly please provide the following inspection-related documents in electronic PDF Format: The 483 (in electronic format) for the Biologics inspection of New York Blood Center Enterprises, located at 905 Walt Whitman Rd, Melville, Ny 11…

Requester: Joshua Boloy - Redica Systems

Good Day! Based on the inspections listing we requested and received from the FDA, kindly please provide the following inspection-related documents in electronic PDF Format: The 483 (in electronic format) for the Biologics inspection of Octapharma S.A.S., located at 72 Rue Du Maréchal Foch, Lingolsheim, 67380, France …

Requester: Joshua Boloy - Redica Systems

On June 5, 2024, we submitted FOIA 2024-4921 requesting all publicly available cosmetic registration data submitted to FDA per new MoCRA requirements. On about July 24, 2024, we received two spreadsheets in response to FOIA 2024-4921: - FOIA 2024-4921 Cosmetic Product Facility Registration Report_Redacted - FOIA 2024-…

Requester: Richard Anturiano-Chavez - Registrar Corp

Request the agency to provide the approval letter for the application A085447 for CHLORDIAZEPOXIDE HYDROCHLORIDE Capsules,5 mg, 10 mg and 25 mg held by ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV

Requester: Preetha Rajamurthy - Novitium Pharma LLC

Please provide the following 1 inspection-related documents in electronic PDF format: The 483 of Norbrook Laboratories Limited; Carnbane Industrial Estate, Newry, GB; FEI: 3005587188; Inspection end date: 04/04/2025

Requester: Markus Felgenhauer - QYOBO GmbH

May I request for our Establishment Inspection Report (EIR) Facility Name: Aiza's Sweets Address: Santo Tomas, Sasmuan, Pampanga, Philippines 2004 FEI: 3005262266 Inspection End Date: April 20, 2018 Inspection ID: 1062447

Requester: LYRA AMPARO - AIZA'S SWEETS

Good Day! Based on the inspections listing we requested and received from the FDA, kindly please provide the following inspection-related documents in electronic PDF Format: The 483 (in electronic format) for the Medical Devices inspection of Stille AB, located at Ekbacken 11, Torshalla, Sweden, inspection ending 09/2…

Requester: Joshua Boloy - Redica Systems

I request copies of records related to the FDA inspection of the Kite Pharma, Inc. manufacturing facility located at 9021 Bennett Creek Blvd, Frederick, MD 21704, that resulted in a Voluntary Action Indicated (VAI) classification.Specifically, I request:The Establishment Inspection Report (EIR);Form FDA 483, if issued…

Requester: Natasha Zawislak - Hudson Bay

This is a FOIA request related to litigation filed in the District of Massachusetts, SEC v. Carchedi, et al., No. 1:25-cv-10599 (D. Mass.). The requested documents pertain to IND No. 068301, NDA No. 214441, and PMA No. P210012. Please refer to the attached letter for detailed descriptions of the documents requested, t…

Requester: Michael S. Lowe - Troutman Pepper Locke LLP

Good Day! Based on the inspections listing we requested and received from the FDA, kindly please provide the following inspection-related documents in electronic PDF Format: The 483 (in electronic format) for the Medical Devices inspection of Next Medical Products Company, LLC, located at 45 Columbia RD, Branchburg, N…

Requester: Joshua Boloy - Redica Systems

Please share the Form 483 for CTON Corporation. Inspection details: • End Date: Jul 25, 2025 • Site: CTON Corporation, Torrance, United States • FEI Number: 3012098634

Requester: Sonika Shinghal - Sovish

Please provide the summary basis of approval and any other releasable documents in the review package for: Drug: Bimzelx (Psoriatic Arthritis) BLA 761151/S-005 Approval Date: 9/20/24 Please provide the documents electronically by email if possible.

Requester: Kristen Sellers - FOIA Professional Services

FDA CVM has Compliance Policy relating to pet food and rendered ingredients. CPG 675.400 Rendered Animal Feed Ingredients and CPG 690.300 Canned Pet Food are the Compliance Policies that I am requesting data on. I am requesting the CVM data that these Compliance Policies were based on – specifically the data that prov…

Requester: Kohl Harrington - Harrington Films

Good Day! Based on the inspections listing we requested and received from the FDA, kindly please provide the following inspection-related documents in electronic PDF Format: The 483 (in electronic format) for the Biologics inspection of Bioreliance Ltd., located at Todd Campus Glasgow West Of Scotland Science Park, Gl…

Requester: Jhan Ray Barril - Redica Systems

Good Day! Based on the inspections listing we requested and received from the FDA, kindly please provide the following inspection-related documents in electronic PDF Format: The 483 (in electronic format) for the Biologics inspection of AbbVie Bioresearch Center, located at 100 Research DRIVE, Worcester, Massachusetts…

Requester: Jhan Ray Barril - Redica Systems

Good Day! Based on the inspections listing we requested and received from the FDA, kindly provide the following inspection-related documents in electronic PDF Format: The 483 (in electronic format) for the Biologics inspection of Grifols Diagnostic Solutions, Inc., located at 4560 Horton ST, Emeryville, CA 94608-2916,…

Requester: Jhan Ray Barril - Redica Systems

Any information from the sponsor's (Hoffmann-La Roche) trial protocol about if there was a non-inferiority margin defined for or present in the sponsor trial protocol for NCT04544449 (FENtrepid). Any information about whether this trial protocol contained or didn't contain prespecified alpha for superiority (FENtrepid…

Requester: Kaylin bower

Full submission and records related to 510k K250031

Requester: Jay Kelley - Kelley MedTech Consulting

To the FDA Freedom of Information Office, Pursuant to the Freedom of Information Act, 5 U.S.C. § 552, I am requesting copies of records related to the following FDA premarket notification submission: • 510(k) Number: K092342 • Device Trade Name: SmartPill • Applicant / Manufacturer: The Smartpill Corporation And, • 51…

Requester: Allison Lockwood - Atmo Biosciences

For Unredacted copy of Bioequivalence Review for Cyclocort® Cream 0.025%, NDA 018116. Approved: October 18, 1979. Applicant: ASTELLAS PHARMA US INC.

Requester: Umesh Pai/OritK - Sun Pharmaceutical Industries,

I request copies of all records in the possession of the U.S. Food and Drug Administration relating to nonclinical toxicology studies of fluoxetine attributed to, authored by, or referenced as “Beck” or “Beck et al.” conducted or submitted circa 2003–2005. Specifically, I request all documentation, including but not l…

Requester: Evan Alexander

Please provide the Establishment Inspection Report (EIR) and the FMD-145 Closure Letter for the following facility inspection that was conducted by FDA on August 15-16, 2023: Sterigenics US LLC 1003 Lakeside Drive Gurnee, IL 60031-2489 Facility Establishment Identifier (FEI): 3000215273

Requester: Michael Levitt - Johnson & Johnson

The form 483 inspection report or state equivalent generated from the BIOL (center) Biologics (product area) inspection of the following foreign facility in the month of December, 2025: - Bioreliance Ltd., Todd Campus, West Of Scotland Science Park, Glasgow, United Kingdom - Operation date, report date, (last) date of…

Requester: Mike Williams - The Capitol Forum

The form 483 inspection report or state equivalent generated from the BIOL (center) Biologics (product area) inspection of the following US facility in the month of December, 2025: - BioLife Plasma Services LP, 4620 Bryant Irvin Rd Ste 516, Fort Worth, TX, 76132-3611, United States - Operation date, report date, (last…

Requester: Mike Williams - The Capitol Forum

The form 483 inspection report or state equivalent generated from the BIOL (center) Biologics (product area) inspection of the following US facility in the month of December, 2025: - Utah Valley Hospital, 1034 N 500 W, Provo, UT, 84604-3380, United States - Operation date, report date, (last) date of inspection and / …

Requester: Mike Williams - The Capitol Forum

The form 483 inspection report or state equivalent generated from the BIOL (center) Biologics (product area) inspection of the following US facility in the month of December, 2025: - Biomat USA, Inc, 1743 Maysville Ave, Zanesville, OH, 43701-5848, United States - Operation date, report date, (last) date of inspection …

Requester: Mike Williams - The Capitol Forum

The form 483 inspection report or state equivalent generated from the BIOL (center) Biologics (product area) inspection of the following foreign facility in the month of December, 2025: - Bavarian Nordic A/S, Hejreskovvej 10a, Kvistgard, Denmark - Operation date, report date, (last) date of inspection and / or date is…

Requester: Mike Williams - The Capitol Forum

Hello, I am requesting the case narratives relating to FAERS with "Suspect Product Names" of Elevidys with the following case IDs: 26334355, 26327771, 26273543, 25629983, 26007918, 25942045, 25941848, 26296981, 24679098, 26244072, 25281921, 24468147. These records are for our personal use. Thanks, Kenny

Requester: Kenny Storch - Diadema Partners

On behalf of BridgeBio Pharma we are requesting a digital (PDF) of a unreacted version of all documents included in the Summary Basis of Approval for NDA 216540 (ATTRUBY) including the Product Quality Review(s), Integrated Review, Proprietary Name Review, Officer/Employee List, Other Review, Risk Assessment and Risk M…

Requester: Paul Pisacane - BridgeBio Pharma, Inc.

This request is submitted by counsel on behalf of Laser Pharmaceuticals, LLC ("Laser"): Pursuant to the Freedom of Information Act, the following records are requested relating to Unipack LLC ("Unipack"): 1. All FDA Form 483(s) issued to Unipack in connection with the FDA inspection conducted June 11–30, 2025 (the "In…

Requester: Jessica H. Leach - Laser Pharmaceuticals, LLC

Any email correspondence between your agency and anyone for the month of January 2026 with the domain name @blueorcacapital.com, @viceroyresearch.com, @muddywaterscapital.com, @scorpioncapital.com, @alderlaneeggs.com, @thebearcave.com, @cablecarcapital.com, @brontecapital.com, @grizzlyreports.com, @bleeckerstreetresea…

Requester: Joe O'Donnell - Canary Data

In a memo dated 05/02/2018, Daniel G. McChesney, Ph.D. makes the claim that "FDA has determined that this represents a serious health hazard because salmonella can cause serious infections and death in pets, and through cross contamination, in people, especially children, the elderly, and people with compromised immun…

Requester: Kohl Harrington - Harrington Films

Calendar records for FDA-CVM employee Charlotte Conway, dates 09.01.25-10.31.25

Requester: Harry Duty

all communications between USAO relevant departments within it and Johnson (a U.S. Corporation), and/or Alcon/Novartis.

Requester: Raoul Doukhie - Federal Corrections Institute, Miami

Requesting the following 510(k) submission records/sections for K221163: Tunnel Crossing Catheter. 1. Substantial Equivalence Discussion 2. Performance Testing (Bench) 3. Performance Testing (Clinical) 4. Performance Testing (Animal)

Requester: Sandeep Chiplonkar - Terumo Medical Corporation

I want the names, titles, salaries, and badge numbers of every single FDA/Criminal Investigation agent that participated in the raid that took place at Affordatox, LLC. 21 Castleford Way Middlesboro, KY 40965 on or around January 29th 2025. I want all disciplinary records for Ethan Simms. I want a copy of the search w…

Requester: Ali Z. Omar

We are looking to get a copy of our annual report from last year. We are the first party. Accession Number: 2430406-000

Requester: Jori Baker - BEA Lasers

Please SEE all attachments. Pursuant to the Freedom of Information Act, 5 U.S.C. § 552, I am requesting access to the following records: All internal and external communications (emails, memos, letters, reports, logs, briefings) between HHS (including NIH, FDA, and OIG) and representatives or investigators from Amarex…

Requester: Daniel Rizzo - FireGate Bioscience LLC

We are requesting the Form 483 inspection reports fo the following businesses at the associated addresses for inpsections on or about the associated date: 1. Joseph J.T. Sacco, MD [Wirral / United Kingdom of Great Britain and Northern Ireland] Street Address: CLATTERBRIDGE ROAD, CLATTERBRIDGE CANCER CENTRE, BIRKENHEAD…

Requester: - FOIA Document Source