# FDA 483 - Zaklady Farmaceutyczne Polpharma S.A. - May 25, 2018

Source: https://www.globalkeysolutions.net/records/483/zaklady-farmaceutyczne-polpharma-sa/ec4c4195-46a2-4fac-9836-57f1bc62e904

> FDA 483 for Zaklady Farmaceutyczne Polpharma S.A. on May 25, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Zaklady Farmaceutyczne Polpharma S.A.
- Inspection Date: 2018-05-25
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Zaklady Farmaceutyczne Polpharma S.A. in Starogard Gdanski, Poland, revealed significant deficiencies in quality control and adherence to written procedures. The firm failed to follow its stability sample handling SOP, resulting in numerous deviations and delayed analyses. Additionally, a high number of out-of-specification results were attributed to analyst error, indicating inadequate employee training.

## Related Officers

- [Consumer Safety Officer](https://www.globalkeysolutions.net/people/darren-s-brown/389a4d1f-7f34-42cd-bdc8-5bebd41aff56)

Company: https://www.globalkeysolutions.net/companies/zaklady-farmaceutyczne-polpharma-sa/f59abed7-7196-4b5f-ae0e-3286e2e8de39

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