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

Source: https://www.keypedia.com/records/483/biotika-as/d34036cd-4b44-4ec7-8105-3ec2d4d8d0af

> 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: Center for Drug Evaluation and Research
- Summary: On June 1, 2018, the FDA issued a Form 483 to Biotika, a pharmaceutical manufacturer located in Martin, Slovakia, following an inspection. The inspection revealed significant deficiencies in the company's quality control and manufacturing processes, particularly concerning the production of sterile drug products.

**Key Observations:**

1.  **Lack of Aseptic Process Simulation:** Biotika failed to conduct aseptic process simulations (media fills) for its sterile drug products. This is a critical omission, as media fills are essential to validate the aseptic processing environment and ensure the sterility of the final product. The absence of these simulations means there is no documented evidence that the manufacturing process can consistently produce sterile drugs, posing a significant risk to patient safety.

2.  **Inadequate Environmental Monitoring:** The environmental monitoring program in the aseptic processing areas was found to be deficient. Specifically, the company did not routinely monitor for viable microorganisms in critical areas during active sterile drug production. This lack of continuous monitoring means that potential microbial contamination events might go undetected, compromising the sterility of the drug products manufactured in these environments.

3.  **Insufficient Investigation of Sterility Failures:** Biotika failed to adequately investigate sterility test failures. The document indicates that when sterility failures occurred, the investigations were not thorough enough to identify the root cause and implement effective corrective and preventive actions (CAPAs). This suggests a systemic issue in addressing quality deviations, increasing the risk of contaminated products reaching the market.

## Related Documents

- [483 - 2018-06-01](https://www.keypedia.com/records/483/biotika-as/e49a8405-f2ff-4f1b-aaf5-285b0fc6a49c)

## Related Officers

- [Consumer Safety Officer](https://www.keypedia.com/people/tiara-m-brown/bbc93754-69de-4379-b9f5-f85ea4c8b0e9)

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

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c