# FDA 483 - RLC Labs Inc. - March 05, 2020

Source: https://www.globalkeysolutions.net/records/483/rlc-labs-inc/b0600bfd-f720-4bf2-a5bf-07bf9a1b95ba

> FDA 483 for RLC Labs Inc. on March 05, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: RLC Labs Inc.
- Inspection Date: 2020-03-05
- Product Type: drugs
- Office Name: Denver District Office
- Summary: RLC Labs Inc. in Phoenix, AZ, a drug product manufacturer, was inspected and found to have significant deficiencies across its quality system, production, and material controls. The firm lacks a functional quality control unit, proper stability testing, validated specifications, and adequate complaint handling, indicating a broad failure to adhere to GMP regulations. These issues raise concerns about the identity, strength, quality, and purity of its drug products, including Nature-Throid and WP Thyroid.

## Related Documents

- [WARNING_LETTER - 2020-03-05](https://www.globalkeysolutions.net/records/warning_letter/rlc-labs-inc/c3c5b827-dca9-406d-b2d3-6ba1340c15e9)
- [483 - 2021-11-04](https://www.globalkeysolutions.net/records/483/rlc-labs-inc/acb9c71f-7da5-4202-9afd-14df307a7ff1)
- [483 - 2023-09-15](https://www.globalkeysolutions.net/records/483/rlc-labs-inc/13248e54-e3eb-4a32-a851-5714545af81e)
- [483 - 2023-11-02](https://www.globalkeysolutions.net/records/483/rlc-labs-inc/177c1f22-e20c-4bc1-8b53-7a77a3bf1193)

## Related Officers

- [other](https://www.globalkeysolutions.net/people/carlie-hughes/a548927e-536b-450b-8c6d-bf7b59395622)
- [Christopher M. Jenner](https://www.globalkeysolutions.net/people/christopher-m-jenner/d2fbd516-71aa-4263-8ffb-57b8149d6b64)

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

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