# FDA 483 - RLC Labs Inc. - September 15, 2023

Source: https://www.keypedia.com/records/483/rlc-labs-inc/13248e54-e3eb-4a32-a851-5714545af81e

> FDA 483 for RLC Labs Inc. on September 15, 2023. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: RLC Labs Inc.
- Inspection Date: 2023-09-15
- Product Type: drugs
- Office Name: Denver District Office
- Summary: Specialty Process Labs LLC in Phoenix, AZ, an Active Pharmaceutical Ingredient (API) manufacturer, received a Form 483 citing three significant observations. The firm failed to ensure the timely destruction of recalled drug products, lacked documented procedures for laboratory data control and sample chain-of-custody, and did not have an adequate ongoing stability testing program for its intermediates and APIs. These issues highlight serious deficiencies in quality control and data integrity.

## Related Documents

- [483 - 2020-03-05](https://www.keypedia.com/records/483/rlc-labs-inc/b0600bfd-f720-4bf2-a5bf-07bf9a1b95ba)
- [WARNING_LETTER - 2020-03-05](https://www.keypedia.com/records/warning_letter/rlc-labs-inc/c3c5b827-dca9-406d-b2d3-6ba1340c15e9)
- [483 - 2021-11-04](https://www.keypedia.com/records/483/rlc-labs-inc/acb9c71f-7da5-4202-9afd-14df307a7ff1)
- [483 - 2023-11-02](https://www.keypedia.com/records/483/rlc-labs-inc/177c1f22-e20c-4bc1-8b53-7a77a3bf1193)

## Related Officers

- [Carrie A. Hughes](https://www.keypedia.com/people/carrie-a-hughes/099d1128-0ba9-4e7a-a0d2-8c10083811c9)
- [Cecilia H. Kieu](https://www.keypedia.com/people/cecilia-h-kieu/3ba5feb0-d49e-4301-ae5c-b84bd604a159)

Company: https://www.keypedia.com/companies/rlc-labs-inc/1b81a5c1-d6cf-4440-8359-bc59f096d8db

Office: https://www.keypedia.com/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face