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

Source: https://www.keypedia.com/records/483/micra-biotechnologies-inc/bea32846-19f4-4877-8f20-bac0deea3ebf

> 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: Dallas District, Fort Worth Resident Post
- Summary: Micra Biotechnologies, Inc., a contract testing laboratory in River Edge, NJ, received an FDA Form 483 following an inspection conducted from July 29 to August 2, 2024. The inspection identified several critical deficiencies in the firm's operations and quality management system. Key observations included the quality control unit failing to follow written procedures, evidenced by unreviewed equipment logs and incomplete documentation for media preparation. The firm also lacked formal quality agreements with clients and had not conducted Good Manufacturing Practice (GMP) training for employees involved in antibiotic microbial assays since May 2018. 

Significant issues were noted in laboratory controls, such as consistent failure to adhere to established standard operating procedures for water purification testing, laboratory cleaning, stock culture maintenance, and sterilization monitoring. Investigations into out-of-specification results were also found to be lacking proper documentation and scientific evidence. Furthermore, the firm failed to conduct essential growth promotion testing for media, utilize properly calibrated pH meters and pipettes, and routinely used expired reagents and media. Inadequate facility controls were observed, specifically a shared refrigerator for drug samples, expired materials, and culture plates, presenting a clear risk of cross-contamination. These observations highlight a need for immediate and comprehensive corrective actions to ensure compliance with regulatory standards.

## Related Documents

- [483 - 2024-08-02](https://www.keypedia.com/records/483/micra-biotechnologies-inc/55a9ae37-fc89-4e66-b579-738d8b5848d0)

## Related Officers

- [Anne P. Reid](https://www.keypedia.com/people/anne-p-reid/123cf007-29c4-4da6-83c3-228c8af415dc)

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

Office: https://www.keypedia.com/offices/dallas-district-fort-worth-resident-post/4c0a9dac-ff7f-49c2-9f90-aa7537236b2a