# FDA 483 - Micra Biotechnologies, Inc. - August 02, 2024

Source: https://www.globalkeysolutions.net/records/483/micra-biotechnologies-inc/55a9ae37-fc89-4e66-b579-738d8b5848d0

> FDA 483 for Micra Biotechnologies, Inc. on August 02, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Micra Biotechnologies, Inc.
- Inspection Date: 2024-08-02
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: Micra Biotechnologies, Inc., a contract testing laboratory in River Edge, NJ, was inspected and received a Form 483 with five observations. The inspection revealed significant deficiencies across quality control, employee training, adherence to established laboratory procedures, and overall laboratory controls, indicating a systemic lack of compliance with CGMP requirements. Issues included inadequate documentation, uncalibrated equipment, lack of growth promotion testing, and poor housekeeping and contamination prevention.

## Related Officers

- [Investigator ](https://www.globalkeysolutions.net/people/juanita-p-versace/dca6c7fb-62ac-4b06-9c77-dbf52fc83422)

Company: https://www.globalkeysolutions.net/companies/micra-biotechnologies-inc/11f16777-7d84-418d-ab67-21398fe9a01d

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