# FDA 483 - AqVida GmbH - June 03, 2022

Source: https://www.keypedia.com/records/483/aqvida-gmbh/cf26f43e-77a1-4732-8db4-d5924b1f6b3e

> FDA 483 for AqVida GmbH on June 03, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: AqVida GmbH
- Inspection Date: 2022-06-03
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: AqVida GmbH, a sterile drug manufacturer in Dassow, Germany, was inspected by the FDA from May 26 to June 3, 2022. The inspection revealed two significant issues: a lack of procedures for visually examining reserve drug product samples annually for deterioration, and inadequate procedures to prevent microbiological contamination of sterile drug products, specifically concerning the cleanability of a cutting device.

## Related Officers

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

Company: https://www.keypedia.com/companies/aqvida-gmbh/ea5c16b0-2c9c-42ee-9602-9233673c0b29

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