# FDA 483 - Minaris Regenerative Medicine, LLC - Unknown Date

Source: https://www.keypedia.com/records/483/minaris-regenerative-medicine-llc/ed6b57d3-0745-471a-8523-3c96bba2baeb

> FDA 483 for Minaris Regenerative Medicine, LLC on Unknown Date. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Minaris Regenerative Medicine, LLC
- Product Type: biologics
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Minaris Regenerative Medicine LLC in Allendale, NJ, identified multiple failures to adhere to written standard operating procedures during production, particularly in aseptic operations. These deficiencies included improper cleanroom practices, incorrect handling of cellular source material, unsafe needle capping techniques, and neglected post-use procedures for a controlled rate freezer. The findings indicate a significant lack of compliance with established protocols, which could impact product quality and safety.

## Related Officers

- [investigator](https://www.keypedia.com/people/graeme-price/2e90c3ca-06df-4350-beb7-2c7576de3e06)
- [Phillip Chu](https://www.keypedia.com/people/phillip-chu/8fa959c1-8e84-4f18-8d84-361149711fb5)
- [Christine Harman](https://www.keypedia.com/people/christine-harman/916fa691-117d-446b-8b53-7413194e3eda)
- [Alan G. Baer](https://www.keypedia.com/people/alan-g-baer/bd794982-d4e0-4b9d-831b-5daa05edda54)

Company: https://www.keypedia.com/companies/minaris-regenerative-medicine-llc/b5fdb186-e2e7-416c-b89e-66d15dbf5509

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd