# FDA 483 - Calmo Manufacturing, Inc - August 23, 2019

Source: https://www.globalkeysolutions.net/records/483/calmo-manufacturing-inc/d0fb6aa0-e8c7-4e92-ab5e-0c5472ab025f

> FDA 483 for Calmo Manufacturing, Inc on August 23, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Calmo Manufacturing, Inc
- Inspection Date: 2019-08-23
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Ca-Leo Manufacturing, Inc. in Huntington Beach, CA, was cited for significant deficiencies during an FDA inspection from August 19-23, 2019. The firm lacked essential written procedures for quality control unit responsibilities, deviation investigations, change control, and electronic data backup. Additionally, observations included failure to requalify stability chambers, inadequate oversight of contract laboratories, and issues with electronic record retention.

## Related Officers

- [Consumer Safety Officer](https://www.globalkeysolutions.net/people/darren-s-brown/389a4d1f-7f34-42cd-bdc8-5bebd41aff56)

Company: https://www.globalkeysolutions.net/companies/calmo-manufacturing-inc/2c80fffe-2e5f-4e91-bbb8-92cf1ada9b15

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