# FDA 483 - RLC Labs Inc. - November 04, 2021

Source: https://www.globalkeysolutions.net/records/483/rlc-labs-inc/acb9c71f-7da5-4202-9afd-14df307a7ff1

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

---

## Details

- Record Type: 483
- Company Name: RLC Labs Inc.
- Inspection Date: 2021-11-04
- Product Type: drugs
- Office Name: Denver District Office
- Summary: RLC Labs Inc., a manufacturer in Phoenix, AZ, was cited for two observations during an FDA inspection. The firm failed to ensure complete backup data for temperature/humidity monitoring in its materials warehouse and lacked a routine calibration program for the monitoring equipment used to store finished drug thyroid tablets and active pharmaceutical ingredients. These issues indicate deficiencies in data integrity and equipment control.

## Related Documents

- [483 - 2020-03-05](https://www.globalkeysolutions.net/records/483/rlc-labs-inc/b0600bfd-f720-4bf2-a5bf-07bf9a1b95ba)
- [WARNING_LETTER - 2020-03-05](https://www.globalkeysolutions.net/records/warning_letter/rlc-labs-inc/c3c5b827-dca9-406d-b2d3-6ba1340c15e9)
- [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

- [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