# FDA 483 - PharmaZell GmbH - September 22, 2017

Source: https://www.keypedia.com/records/483/pharmazell-gmbh/06be9ec5-429c-4b6a-a924-9fc73776de4e

> FDA 483 for PharmaZell GmbH on September 22, 2017. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: PharmaZell GmbH
- Inspection Date: 2017-09-22
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of PharmaZell GmbH, an API drug manufacturer in Raubling, Germany, revealed significant deficiencies across its operations. The firm's quality control unit failed to adequately address a high number of deviations, many stemming from human errors, with insufficient corrective actions. Additionally, laboratory controls were found lacking due to incomplete test method validations and a deficient stability program for API drug products, impacting the determination of appropriate expiration dates.

## Related Documents

- [EIR - 2017-09-22](https://www.keypedia.com/records/eir/pharmazell-gmbh/17d23f1c-e250-45e6-b378-97634bba0c25)

## Related Officers

- [Drug Investigator](https://www.keypedia.com/people/deyaa-shaheen/ebbabce5-347c-4de4-abed-ba9da11c26ed)

Company: https://www.keypedia.com/companies/pharmazell-gmbh/37149959-807d-41b5-be90-cc07ca5a6098

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd