An information request regarding US Food and Drug Administration inspections of Pfizer facilities received redacted answers and prompted further questions.Amy Kelly, COO of DailyClout and Project Director for the WarRoom/DailyClout Pfizer and Moderna Documents Analysis Project, asked the 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.On DailyClout, Kelly said her outlet would release a fuller analysis later, but the responses were noteworthy enough to warrant their immediate release.“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," she wrote.The inquiries covered 15 facilities in the US and Europe. A reply sent by the Center for Biologics Evaluation and Research (CBER), a division of the FDA, said, “After a thorough and diligent investigation, a search of our records did not locate any CBER inspections responsive to your request” for six of the 15 facilities. They were located in Missouri, Michigan, New York, Croatia, Belgium and Germany.The reply only revealed two inspection reports. One was from Pfizer Manufacturing Belgium NV in Puurs, Belgium ending July 2, 2021 and another from Wyeth Biopharma Division of Wyeth Pharmaceuticals LLC in Andover, Massachusetts ending July 23, 2021.The Weyth inspection revealed numerous problems related to the quality, production, facilities, equipment and laboratory control systems to manufacture the BNT162b2 drug substance, the COVID-19 vaccine. However, some of the text was redacted, under Exemption (b)(4). This “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.”The 86-page inspection report for the Wyeth facility said the previous inspection had been done in spring 2019 and identified three issues. However, the 2021 inspection outlined 13 problems in a single paragraph.“(1) There is insufficient data to support product quality prior to the release of BNT162b2 DS batch; (2) There is inadequate quality oversight; (3) Deviation investigations were deficient; (4) Cleaning validation had not been performed on…building [redacted]; (5) Cleaning of…product-contact parts using [redacted] is not validated; (6) Cleaning efficacy studies are inadequate…(7) The ISO-[redacted] are not monitored to ISO [redacted] standards; (8) Routine monitoring of the compressed air of Building [redacted] does not adequately represent all points of use; (9) The environmental program…is deficient in ensuring that the cleanrooms are operating in a state of environmental control; (10) Clean status of the room is not verified or documented in the batch record after a preventive maintenance that resulted in a lack of pressure differential; (11) Standard operating procedures are not followed; (12) Facility deficiencies observed; and (13) Documentation of raw material storage is inadequate,” the inspection stated.“Verbal observations were also made at the conclusion of the inspection. The firm’s management stated that they would provide a response to the inspectional observations within 15 days.”The inspection of the Belgium facility was the first one made there since November 2017, when no problems were found. At neither time was an FDA Form 483 “Inspectional Observations” issued, though the seven-day inspection in 2021 did prompt “some discussion items.” Inspector Anissa Cheung discussed closing remarks with Pieter Verbelen, Launch Excellence Director to conclude the inspection.Regulations required “deviation reporting” for “unplanned incidents for drug products activities, including but not limited to production, testing, distribution.” In the inspection report, Cheung noted, “I reviewed more than 50 product or process-related deviations. The majority of these were recurrent. One deviation involved multiple final DP batches that demonstrated lower than expected [redacted].” However, the problem seemed to have been corrected.On another occasion, problems with “bioburden and endotoxin results” were prompted by a “spill on the floor” and operators who attached the [redacted] without disinfecting their gloves. Four corrective actions were taken to solve the problem.Redactions were also made for privacy reasons and a reason Kelly found even more noteworthy."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," Kelly wrote.DailyClout is still waiting for inspection reports on the other seven facilities.
