# FDA 483 - CMIC CMO USA Corporation - May 04, 2021

Source: https://www.globalkeysolutions.net/records/483/cmic-cmo-usa-corporation/6d53d38f-5712-443f-9700-6268dda4075c

> FDA 483 for CMIC CMO USA Corporation on May 04, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: CMIC CMO USA Corporation
- Inspection Date: 2021-05-04
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: An FDA inspection of CMIC CMO USA Corporation in Cranbury, NJ, a pharmaceutical manufacturer, revealed two significant observations. The firm failed to establish appropriate time limits for production phases, specifically lacking in-process hold-time parameters for drug product manufacturing. Additionally, the company's electronic record system for equipment maintenance and calibration was found to be ineffective, failing to ensure trustworthiness and reliability.

## Related Officers

- [Ankur C. Patel](https://www.globalkeysolutions.net/people/ankur-c-patel/602c7d14-2c48-4929-a07b-6e4c235d7f13)
- [Russell J. Glapion](https://www.globalkeysolutions.net/people/russell-j-glapion/54dd6274-563a-44fe-8016-2ebd700be7a0)

Company: https://www.globalkeysolutions.net/companies/cmic-cmo-usa-corporation/026de3c9-7077-4859-bf21-6304c0c50f29

Office: https://www.globalkeysolutions.net/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248