# FDA 483 - allphamed PHARBIL Arzneimittel GmbH - July 12, 2019

Source: https://www.keypedia.com/records/483/allphamed-pharbil-arzneimittel-gmbh/0bd7ee82-f7d8-461a-961b-ef8a53c5ee30

> FDA 483 for allphamed PHARBIL Arzneimittel GmbH on July 12, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: allphamed PHARBIL Arzneimittel GmbH
- Inspection Date: 2019-07-12
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of allphamed PHARBIL Arzneimittel GmbH in Gottingen, Germany, revealed multiple deficiencies in their manufacturing operations. The firm was cited for inadequate batch production and laboratory records, insufficient laboratory controls for visual tests, and failure to follow written production procedures. Other issues included a lack of equipment cleaning records, inadequate employee training on SOPs, and a quality control unit that did not fully adhere to its responsibilities.

## Related Officers

- [Consumer Safety Officer (Inspector)](https://www.keypedia.com/people/christopher-r-czajka/42defbf3-ea06-4090-8d51-7da2b07d9e84)

Company: https://www.keypedia.com/companies/allphamed-pharbil-arzneimittel-gmbh/5f5dbcea-8898-466c-a71e-ac9037437465

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