FOIA’d FDA ‘Establishment Inspection Reports’ of Pfizer COVID Vaccine Manufacturing Facilities Reveal “Inadequate Quality Oversight,” Deficient Deviation Investigations, Ignored Standard Operating Procedures, and More.

Amy Kelly, COO of DailyClout.io and Project Director for the WarRoom/DailyClout Pfizer and Moderna Documents Analysis Project, received a partial production of documents in response to her Freedom of Information Act (FOIA) request submitted to the Food and Drug Administration (FDA) for “all FDA inspection reports from inspections of Pfizer manufacturing facilities, both domestically and internationally, used in the manufacturing of Pfizer’s COVID-19 vaccine, BNT162b2, drug as well as Pfizer’s COVID-19 vaccine boosters” for the date range of January 1, 2020, through October 31, 2023. Ms. Kelly’s FOIA request specified that the FDA search for inspection reports for the following manufacturing facilities:

1. Pfizer Inc. 875 Chesterfield Parkway West, Chesterfield, MO 63017
2. Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC 1 Burt Road Andover, MA 01810
3. Pharmacia & Upjohn Company LLC 7000 Portage Road Kalamazoo, MI 49001
4. Pfizer Manufacturing Belgium NV Rijksweg 12 Puurs, 2870 Belgium
5. Pfizer Ireland Pharmaceuticals Grange Castle Business Park Clondalkin, Dublin 22 Ireland
6. Hospira Zagreb Ltd Prudnicka cesta 60 10291 Prigorje Brdovecko Croatia
7. SGS Lab Simon SA Vieux Chemin due Poete 10 Wavre, 1301 Belgium
8. Hospira, Inc., McPherson, Kansas (Pfizer, McPherson)
9. BioNTech Marburg, Germany
10. Pfizer Inc. 875 Chesterfield Parkway West, Chesterfield, MO 63017
11. Pharmacia & Upjohn Company LLC 7000 Portage Road Kalamazoo, MI 49001
12. Hospira Zagreb Ltd Prudnicka cesta 60 10291 Prigorje Brdovecko Croatia
13. SGS Lab Simon SA Vieux Chemin due Poete 10 Wavre, 1301 Belgium
14. BioNTech Marburg, Germany
15. Pfizer Pearl River, NY

The inspection reports sent in response to the FOIA show the facilities not following established manufacturing and cleaning procedures, as well generally inadequate quality oversight, thus leading to a concerning decrease in product quality.

The Center for Biologics Evaluation and Research (CBER) sent these documents to Ms. Kelly. CBER is the “center within FDA that regulates biological products for human use under applicable federal laws, including the Public Health Service Act and the Federal Food, Drug and Cosmetic Act. CBER protects and advances the public health by ensuring that biological products are safe and effective and available to those who need them. CBER also provides the public with information to promote the safe and appropriate use of biological products.” (https://www.fda.gov/about-fda/fda-organization/center-biologics-evaluation-and-research-cber) In its response, CBER wrote, “After a thorough and diligent investigation, a search of our records did not locate any CBER inspections responsive to your request for the following locations:

• Pfizer Inc. 875 Chesterfield Parkway West, Chesterfield, MO 63017
• Pharmacia & Upjohn Company LLC 7000 Portage Road Kalamazoo, MI 49001
• Hospira Zagreb Ltd Prudnicka cesta 60 10291 Prigorje Brdovecko Croatia
• SGS Lab Simon SA Vieux Chemin due Poete 10 Wavre, 1301 Belgium
• BioNTech Marburg, Germany
• Pfizer Pearl River, NY” (Bold in original.)

CBER produced only two inspection reports, both of which cover inspections that happened months after the public rollout of Pfizer’s mRNA COVID vaccine: “Establishment Inspection Reports for the inspection of Pfizer Manufacturing Belgium NV in Puurs, Belgium ending July 2,2021 and Wyeth Biopharma Division of Wyeth Pharmaceuticals LLC in Andover, Massachusetts ending July 23,2021.” (Bold added.)

In the letter accompanying the documents production, CBER addressed the three FOIA exemptions used to heavily redact the inspection reports:

“We have withheld portions of pages under Exemption (b)(4), 5 U.S.C. § 552(b)(4). That exemption permits the withholding of trade secrets and commercial or financial information that was obtained from a person outside the government and that is privileged or confidential.

In addition, we have withheld portions of pages under Exemption (b)(6), 5 U.S.C. § 552(b)(6). That exemption protects information from disclosure when its release would cause a clearly unwarranted invasion of personal privacy. FOIA Exemption 6 is available to protect information in personnel or medical files and similar files. This requires a balancing of the public’s right to disclosure against the individual’s right to privacy.

In addition, we have withheld portions of pages under Exemption (b)(7), 5 U.S.C. § 552(b)(7). That exemption protects from disclosure records or information compiled for law enforcement purposes, but only to the extent that the production of such law enforcement records or information (A) could reasonably be expected to interfere with enforcement proceedings, (B) would deprive a person of a right to a fair trial or an impartial adjudication, (C) could reasonably be expected to constitute an unwarranted invasion of personal privacy, (D) could reasonably be expected to disclose the identity of a confidential source, including a State, local, or foreign agency or authority or any private institution which furnished information on a confidential basis, and, in the case of a record or information compiled by a criminal law enforcement authority in the course of a criminal investigation, or by an agency conducting a lawful national security intelligence investigation, information furnished by a confidential source, (E) would disclose techniques and procedures for law enforcement investigations or prosecutions, or would disclose guidelines for law enforcement investigations or prosecutions if such disclosure could reasonably be expected to risk circumvention of the law, or (F) could reasonably be expected to endanger the life or physical safety of any individual.” (Bold and italics added.)

DailyClout finds it to be of particular interest that redaction exemption (b)(7) — an exemption that applies only to records or information compiled for law enforcement purposes — applies to manufacturing facility documentation.

A detailed analysis of the Andover, Massachusetts, and Purrs, Belgium, inspection reports will be posted on DailyClout once the reports are thoroughly reviewed. After seeing concerning information as shown below, DailyClout wants to make these important documents immediately available to the public.

Please read the full inspection reports below.

116_BLA 125742-0_08-21-2021_Inspection Related_Establi
 

92_BLA 125742-0_08-19-2021_Inspection Related_Inspect

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Amy Kelly is the COO of DailyClout.