# FDA WARNING_LETTER - KVK Tech, Inc. - April 16, 2019

Source: https://www.keypedia.com/records/warning_letter/kvk-tech-inc/e52dd09d-9479-459b-9c2a-bdacc44782a5

> FDA WARNING_LETTER for KVK Tech, Inc. on April 16, 2019. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: KVK Tech, Inc.
- Inspection Date: 2019-04-16
- Product Type: Drugs
- Office Name: Division of Pharmaceutical Quality Operations I
- Summary: The FDA issued a Warning Letter to KVK-Tech, Inc. following an inspection from April 9-16, 2019, identifying significant CGMP violations, rendering their drug products adulterated.

Key violations include:
1.  **Failure to establish and document test method accuracy (21 CFR 211.165(e))**: The firm improperly integrated co-eluting peaks during impurity testing of phentermine HCL capsules, leading to missed OOS results. A lot remained on the market until it failed stability testing in June 2017, despite self-identifying the issue in 2016 and conducting training. An SOP cleared by their quality unit contained inadequate integration examples.
2.  **Failure to thoroughly investigate discrepancies (21 CFR 211.192)**: Foreign particles found in methylphenidate oral solution Lot #15315A were not adequately investigated for origin or effect on quality before release. This lot was later recalled.
3.  **Inadequate computer system controls (21 CFR 211.68(b))**: Laboratory data was not adequately protected from deletion or alteration. Quality assurance employees had administrator access to chromatographic software, and data files on stand-alone equipment could be modified without audit trails. Previous corrective actions for data integrity were not fully implemented.

The FDA expressed concern about the firm's data integrity and recommended retaining

## Related Documents

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## Related Officers

- [Market Manager](https://www.keypedia.com/people/lisa-orr/1a0fd214-ce6e-4841-bf52-2fe4239e328a)
- [District Director](https://www.keypedia.com/people/diana-amador-toro/66f3f6c5-4cfe-4f40-b4d4-d24ed4618e64)

Company: https://www.keypedia.com/companies/kvk-tech-inc/f8ea60fc-cfc0-4769-8e62-a677abd59cb9

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-i/6ded4818-ee3a-46a1-84c1-36de58502b02