# FDA 483 - FNC Medical Corporation - December 09, 2022

Source: https://www.globalkeysolutions.net/records/483/fnc-medical-corporation/8cacb406-75d3-4cda-9404-aab59f426d5d

> FDA 483 for FNC Medical Corporation on December 09, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: FNC Medical Corporation
- Inspection Date: 2022-12-09
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: FNC Medical Corporation in Ventura, CA, was inspected and received a Form 483 with four observations. The inspection revealed significant deficiencies in the quality control unit, including inadequate training, failure to follow procedures, poor record-keeping practices, and a lack of proper investigations for out-of-specification results. Additionally, the firm failed to validate test methods, maintain accurate laboratory control records, and ensure proper review of laboratory documentation.

## Related Officers

- [Claudia M. Perez-Kasmarski](https://www.globalkeysolutions.net/people/claudia-m-perez-kasmarski/ee989ba2-eb7a-47ae-8be5-7a28f748343b)

Company: https://www.globalkeysolutions.net/companies/fnc-medical-corporation/71cf8fc1-5e36-40e4-afa4-0c2c7bcd0e30

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