# CTK OTC Laboratories LLC – FDA 483, Mar 8, 2019

Source: https://www.keypedia.com/records/483/ctk-otc-laboratories-llc/107bf47e-65ad-4730-9485-d67b2e82e431

> FDA 483 for CTK OTC Laboratories LLC on March 08, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: CTK OTC Laboratories LLC
- Inspection Date: 2019-03-08
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: BKCLASS, a manufacturer in Corona, CA, was cited for multiple significant deficiencies during an FDA inspection. The firm failed to ensure adequate employee training, follow written procedures for component approval, and maintain complete batch production records. Additionally, the inspection revealed a lack of investigations for unexplained discrepancies, absence of annual product reviews for OTC products, and insufficient equipment qualification and cleaning validation.

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## Related Officers

- [Investigator](https://www.keypedia.com/people/saied-a-asbagh/215bfa90-995f-4310-baf3-cd9d37639b7b)
- [Gurunandan Mavinkurve, MS, RPh, US Agent](https://www.keypedia.com/people/gurunandan-mavinkurve-ms-rph-us-agent/a35e88df-63b3-4288-8742-60e79f72d312)
- [Mr. Aron Shapiro](https://www.keypedia.com/people/mr-aron-shapiro/4e7e6c39-4aa7-4cdc-8a62-620b3479374c)

Company: https://www.keypedia.com/companies/ctk-otc-laboratories-llc/b335f624-1732-48b8-9900-26989b236b51

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6