# FDA 483 - Clinical Formula LLC - December 03, 2021

Source: https://www.globalkeysolutions.net/records/483/clinical-formula-llc/b6b816c7-5541-407a-9fd0-54110f75ce81

> FDA 483 for Clinical Formula LLC on December 03, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Clinical Formula LLC
- Inspection Date: 2021-12-03
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Clinical Formula LLC, a drug manufacturer in Newport Beach, CA, was cited for significant deficiencies across its quality system, laboratory controls, stability testing, manufacturing processes, and materials management. The inspection revealed a lack of a functional quality control unit, scientifically unsound laboratory practices, unvalidated manufacturing processes, and inadequate supplier qualification, indicating a systemic failure to adhere to good manufacturing practices.

## Related Documents

- [WARNING_LETTER - 2022-04-19](https://www.globalkeysolutions.net/records/warning_letter/clinical-formula-llc/f3cbc070-327f-46ff-8e26-5ccde5f19ef2)

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/gavin-t-cua/6f498dd6-2c4b-42e9-8ddc-3c2a7c97afef)
- [Pharmaceutical investigator](https://www.globalkeysolutions.net/people/bryan-a-galvez/d1e52abc-5b56-4ffb-af22-90e6733fb73a)

Company: https://www.globalkeysolutions.net/companies/clinical-formula-llc/8a18d62e-efa3-4bb2-847e-b4fe3a8bdea5

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