# FDA 483 - Custom Research Labs Inc - June 04, 2021

Source: https://www.globalkeysolutions.net/records/483/custom-research-labs-inc/6036197a-ca72-4f14-a203-a1f602cac09d

> FDA 483 for Custom Research Labs Inc on June 04, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Custom Research Labs Inc
- Inspection Date: 2021-06-04
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Custom Research Labs Inc, a drug manufacturer in Gardena, CA, was inspected by the FDA from June 1-4, 2021. The inspection revealed significant deficiencies across multiple quality systems, including inadequate quality control unit procedures, lack of investigations into discrepancies, incomplete production records, and insufficient stability data for drug products. Several observations, such as inadequate annual product reviews, lack of process validation, and absence of stability data, were repeats from a 2016 FDA inspection, indicating persistent non-compliance with GMP regulations.

## Related Documents

- [WARNING_LETTER - 2021-06-04](https://www.globalkeysolutions.net/records/warning_letter/custom-research-labs-inc/73539d10-44eb-409f-b40d-f1d8aa1bd41f)

## Related Officers

- [Dogbeda F. Mackenzie](https://www.globalkeysolutions.net/people/dogbeda-f-mackenzie/c522e2cb-bf53-48f3-b88a-20b7aa0238d6)
- [Consumer Safety Officer](https://www.globalkeysolutions.net/people/jeffrey-p-raimondi/7576ca4e-d9e8-4015-9ae6-9498e76058d3)

Company: https://www.globalkeysolutions.net/companies/custom-research-labs-inc/9b06cc46-d665-4363-bc5e-ab6cf9dfce31

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