# FDA 483 - FMKLABS - December 31, 2024

Source: https://www.globalkeysolutions.net/records/483/fmklabs/8a7ea1e9-bad7-4ed9-87fb-347c8143f473

> FDA 483 for FMKLABS on December 31, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: FMKLABS
- Inspection Date: 2024-12-31
- Product Type: drugs
- Office Name: Los Angeles District Office
- Summary: FMKLABS, a drug manufacturer in Corona, CA, was inspected by the FDA and received a Form 483 with four observations. The inspection revealed significant issues including a failure to investigate out-of-specification results and cleaning validation failures, inadequate process validation and in-process controls, unverified testing methods, and an unvalidated water system. These deficiencies indicate a lack of robust quality control and manufacturing processes.

## Related Documents

- [483 - 2019-03-08](https://www.globalkeysolutions.net/records/483/fmklabs/107bf47e-65ad-4730-9485-d67b2e82e431)
- [WARNING_LETTER - 2024-12-31](https://www.globalkeysolutions.net/records/warning_letter/fmklabs/a22c49f9-c623-482e-9843-06ca7bbed53f)

## Related Officers

- [Pearl C. Ozuruigbo](https://www.globalkeysolutions.net/people/pearl-c-ozuruigbo/28ec383e-a602-4764-8d14-20b1049f93d7)

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

Office: https://www.globalkeysolutions.net/offices/los-angeles-district-office/edcf1dfe-596a-43b8-8df4-07d9cd94763b