# FDA 483 - MONOCENT INC. - August 19, 2021

Source: https://www.globalkeysolutions.net/records/483/monocent-inc/82626fa5-2967-4d7f-91ae-281dbab414e1

> FDA 483 for MONOCENT INC. on August 19, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: MONOCENT INC.
- Inspection Date: 2021-08-19
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of MONOCENT INC. in Chatsworth, CA, from August 17-19, 2021, revealed a significant issue with process control procedures. The firm failed to adequately establish procedures for recording in-process non-conformities during the relabeling and repacking of medical devices. This indicates a lack of robust controls to ensure product conformance to specifications.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/sarah-a-hassas/4f142d54-fc28-4bd5-82ad-7e6fa443688c)

Company: https://www.globalkeysolutions.net/companies/monocent-inc/7ec46181-14fe-480e-89ec-ef28a8f4adff

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