# FDA 483 - FMKLABS - May 04, 2026

Source: https://www.keypedia.com/records/483/fmklabs/90f4127d-b294-43d3-a31f-23dd68147bf9

> FDA 483 for FMKLABS on May 04, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: FMKLABS
- Inspection Date: 2026-05-04
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: CTK OTC Laboratories LLC, a contract manufacturer in Corona, CA, was inspected and cited for significant quality control deficiencies. Observations included failures to investigate out-of-specification results and batch yield discrepancies, inadequate cleaning validation and procedures for shared equipment, and a lack of proper qualification and monitoring for critical laboratory equipment. These issues indicate a systemic failure to ensure product quality and prevent contamination.

## Related Documents

- [483 - 2019-03-08](https://www.keypedia.com/records/483/fmklabs/107bf47e-65ad-4730-9485-d67b2e82e431)
- [483 - 2019-03-08](https://www.keypedia.com/records/483/fmklabs/e78d09fb-902e-447e-b0a2-c93749bfe196)
- [483 - 2024-12-31](https://www.keypedia.com/records/483/fmklabs/8a7ea1e9-bad7-4ed9-87fb-347c8143f473)
- [WARNING_LETTER - 2024-12-31](https://www.keypedia.com/records/warning_letter/fmklabs/a22c49f9-c623-482e-9843-06ca7bbed53f)

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/ngozi-g-offor/d9d0aa28-6bd1-4427-a712-8716c96b1f3d)

Company: https://www.keypedia.com/companies/fmklabs/b335f624-1732-48b8-9900-26989b236b51

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