# FDA 483 - Apotek Production & Laboratorier AB - January 29, 2026

Source: https://www.keypedia.com/records/483/apotek-production-laboratorier-ab/94432165-6cfe-4ed7-b336-d49bb110e249

> FDA 483 for Apotek Production & Laboratorier AB on January 29, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Apotek Production & Laboratorier AB
- Inspection Date: 2026-01-29
- Product Type: drugs
- Office Name: Office of Partnerships
- Summary: An FDA inspection of Apotek Production & Laboratorier AB, a sterile drug manufacturer, revealed significant deficiencies across multiple areas of its quality system. Issues included inadequate validation of aseptic processes, poor aseptic techniques by operators, and a deficient environmental monitoring system. Further concerns were raised regarding incomplete batch records, unsuitable equipment design, lack of data integrity controls for laboratory equipment, and unvalidated laboratory test procedures, all impacting the assurance of sterile drug product quality.

## Related Documents

- [483 - 2026-01-29](https://www.keypedia.com/records/483/apotek-production-laboratorier-ab/3a24e3c4-1270-43e3-b8ba-69df739e4615)

## Related Officers

- [Consumer Safety Officer ](https://www.keypedia.com/people/anastasia-m-shields/a22b8d52-e3f9-4e61-aa3f-6f03ff2f59df)

Company: https://www.keypedia.com/companies/apotek-production-laboratorier-ab/79450c29-5eaa-4d9d-9707-c70f5ba3598f

Office: https://www.keypedia.com/offices/office-of-partnerships/83acc701-fc5a-4876-bb34-7499e31541d3