# FDA 483 - Pfizer Manufacturing Belgium NV - June 08, 2023

Source: https://www.keypedia.com/records/483/pfizer-manufacturing-belgium-nv/a3ec07be-9ab6-4d43-be1a-7f2a3034c654

> FDA 483 for Pfizer Manufacturing Belgium NV on June 08, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pfizer Manufacturing Belgium NV
- Inspection Date: 2023-06-08
- 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, identified one observation related to inadequate documentation of corrective and preventive action (CAPA) activities. Specifically, investigations into injector pen device complaints, such as blockages and underfills, lacked sufficient documentation. This indicates a deficiency in the firm's quality system regarding CAPA record-keeping.

## Related Documents

- [EIR - 2021-07-02](https://www.keypedia.com/records/eir/pfizer-manufacturing-belgium-nv/63404e90-f447-48cd-9cf0-fba58c2cde32)
- [483 - 2024-05-17](https://www.keypedia.com/records/483/pfizer-manufacturing-belgium-nv/77b22a1d-f971-4da8-b621-ecf125be6b16)

## Related Officers

- [Consumer Safety Officer](https://www.keypedia.com/people/catherine-j-laufmann/920b7656-2847-408d-ba15-3989283d8c94)

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