# FDA 483 - Pfizer Manufacturing Belgium NV - May 17, 2024

Source: https://www.keypedia.com/records/483/pfizer-manufacturing-belgium-nv/77b22a1d-f971-4da8-b621-ecf125be6b16

> FDA 483 for Pfizer Manufacturing Belgium NV on May 17, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pfizer Manufacturing Belgium NV
- Inspection Date: 2024-05-17
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Pfizer Manufacturing Belgium NV in Puurs-Sint-Amands, Belgium, revealed significant deficiencies in sterile drug product manufacturing processes, including inadequate sterilization of equipment contact surfaces and environmental monitoring. The inspection also cited failures in following standard operating procedures for endotoxin testing and documentation practices, as well as poor maintenance of critical manufacturing utilities and equipment. These issues raise concerns regarding product quality and sterility assurance.

## Related Documents

- [EIR - 2021-07-02](https://www.keypedia.com/records/eir/pfizer-manufacturing-belgium-nv/63404e90-f447-48cd-9cf0-fba58c2cde32)
- [483 - 2023-06-08](https://www.keypedia.com/records/483/pfizer-manufacturing-belgium-nv/a3ec07be-9ab6-4d43-be1a-7f2a3034c654)

## Related Officers

- [Ayyappan Rathakrishnan](https://www.keypedia.com/people/ayyappan-rathakrishnan/4f1e717b-5d46-4f94-83c8-59eff245cc44)
- [Senior Regulatory Specialist](https://www.keypedia.com/people/wayne-e-seifert/e92e1f10-c61e-4b08-9156-25907e5e2942)

Company: https://www.keypedia.com/companies/pfizer-manufacturing-belgium-nv/9251b625-0cd3-4c3e-8267-f0c88fe32d75

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd