# FDA 483 - Biotika a.s. - June 01, 2018

Source: https://www.globalkeysolutions.net/records/483/biotika-as/e49a8405-f2ff-4f1b-aaf5-285b0fc6a49c

> FDA 483 for Biotika a.s. on June 01, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Biotika a.s.
- Inspection Date: 2018-06-01
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Biotika A.S., an API manufacturer in Slovenska Lupca, Slovakia, revealed significant deficiencies in documentation practices. Observations included incomplete batch production and control records, specifically regarding in-process test results, cleanroom parameters, and water volumes. The firm also failed to adequately document changes to computerized systems, review audit trails, and control user roles, indicating serious data integrity concerns.

## Related Documents

- [483 - 2018-06-01](https://www.globalkeysolutions.net/records/483/biotika-as/d34036cd-4b44-4ec7-8105-3ec2d4d8d0af)

## Related Officers

- [Tiara N Brown-Crosen](https://www.globalkeysolutions.net/people/tiara-n-brown-crosen/8255649d-25a9-49fa-a28d-0cdda922c0c3)

Company: https://www.globalkeysolutions.net/companies/biotika-as/4c5c1151-0c4c-4711-9024-c708204fc0c3

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