Drug factory · FDA FEI 1000654629
Pfizer Manufacturing Belgium NV
Rijksweg 12, Puurs-Sint-Amands, Belgium
Problems found, fixed voluntarily at FDA's last inspection, Jun 22, 2022.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
5 drug inspections on record since 2011: 2 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jun 22, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Nov 16, 2017 | No problems found | Drug Quality Assurance | — |
| Jun 30, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Mar 18, 2014 | No problems found | Drug Quality Assurance | — |
| Sep 23, 2011 | Problems found, fixed voluntarily | Drug Quality Assurance | 5 |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Sep 23, 2011 inspection
- Procedures for sterile drug products 21 CFR 211.113(b)
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and followed. - Instruments, apparatus, et. al. not meeting specs 21 CFR 211.160(b)(4)
The use of apparatus not meeting established specifications was observed. - Investigations of discrepancies, failures 21 CFR 211.192
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed. - Equipment for Environmental Control 21 CFR 211.46(b)
Equipment for adequate control over air pressure is not provided when appropriate for the manufacture, processing, packing or holding of a drug product. - Reactive/Additive/Absorptive Containers/Closures 21 CFR 211.94(a)
Drug product containers or closures are reactive and additive so as to alter the safety, identity, strength, quality, and purity of the drug beyond the official or established requirements.
Registered with FDA for: analysis; label; manufacture; pack.