# FDA 483 - Maropack AG - February 11, 2022

Source: https://www.keypedia.com/records/483/maropack-ag/48f17e2b-6753-499a-b5b2-85b83410a7b2

> FDA 483 for Maropack AG on February 11, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Maropack AG
- Inspection Date: 2022-02-11
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Maropack AG, a sterile pharmaceutical manufacturer in Zell, Switzerland, revealed significant deficiencies in preventing microbiological contamination of sterile drug products. The firm failed to establish and follow procedures for aseptic interventions, conduct adequate deviation investigations for out-of-limit results, and ensure the efficacy of disinfectants. Additionally, the inspection found a lack of written investigations for monitoring excursions and issues with the quality control unit's change control procedures.

## Related Officers

- [ Investigator ](https://www.keypedia.com/people/matthew-b-casale/e78481c6-5fbd-4723-a79c-167176395af8)

Company: https://www.keypedia.com/companies/maropack-ag/d5072896-e4cb-47fa-9dc8-84a2c96466f3

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1