# FDA WARNING_LETTER - FICOSOTA LTD - September 05, 2019

Source: https://www.keypedia.com/records/warning_letter/ficosota-ltd/1a0d24de-d65b-457c-a6a2-1ab2cdbf0a24

> FDA WARNING_LETTER for FICOSOTA LTD on September 05, 2019. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: FICOSOTA LTD
- Inspection Date: 2019-09-05
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: The FDA issued a Warning Letter to FICOSOTA LTD. in Shumen, Bulgaria, following an inspection from September 2-5, 2019, which revealed significant CGMP violations for finished pharmaceuticals, rendering their drug product adulterated.

Key violations include:
1.  **Failure to test finished drug products:** The firm did not perform identity and strength testing for each batch of their OTC drug product "(b)(4)" prior to release, violating 21 CFR 211.165(a).
2.  **Inadequate raw material testing:** The firm failed to test incoming raw materials for identity, purity, strength, and quality, relying on supplier COAs without a robust supplier qualification program, violating 21 CFR 211.84(d)(1) & (2).
3.  **Deficient Quality Control Unit (QCU) oversight:** The QCU failed to ensure CGMP compliance, including approving/rejecting materials, reviewing testing, monitoring process control, adequate master/batch records, annual product reviews, and OOS investigations. The QCU was also not independent from production, violating 21 CFR 211.22.
4.  **Inadequate stability program:** The firm lacked a written stability testing program, including long-term studies with chemical and microbial testing, to support expiration dates, violating 21 CFR 211.166(a

## Related Officers

- [Director](https://www.keypedia.com/people/francis-godwin/1556d203-d47c-4744-af37-2591a163149e)
- [Miglena I. Bankova](https://www.keypedia.com/people/miglena-i-bankova/8e578ba6-31a2-461c-bed9-ddcc7660f9f2)

Company: https://www.keypedia.com/companies/ficosota-ltd/309b39eb-45c2-4aa8-9210-588649638558

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