# FDA 483 - Minaris Regenerative Medicine, LLC - September 29, 2025

Source: https://www.keypedia.com/records/483/minaris-regenerative-medicine-llc/2e8810f5-aad5-4204-886c-ab4e63c9488b

> FDA 483 for Minaris Regenerative Medicine, LLC on September 29, 2025. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Minaris Regenerative Medicine, LLC
- Inspection Date: 2025-09-29
- Product Type: biologics
- Office Name: FDA District Office — Chicago, Illinois
- Summary: An FDA inspection of Minaris Regenerative Medicine, LLC in Allendale, NJ, a contract manufacturer, revealed significant deficiencies in their quality systems. Observations included a failure to establish adequate written procedures for production and process controls, particularly regarding deviation documentation for LYFGENIA. Additionally, the firm lacked written procedures for handling post-marketing adverse drug experiences and failed to document major equipment in batch production records.

## Related Documents

- [EIR - 2017-04-26](https://www.keypedia.com/records/eir/minaris-regenerative-medicine-llc/f1b93700-dcfa-479a-837d-4ccbb24d3ca4)
- [483 - Unknown Date](https://www.keypedia.com/records/483/minaris-regenerative-medicine-llc/ed6b57d3-0745-471a-8523-3c96bba2baeb)
- [483 - 2025-09-29](https://www.keypedia.com/records/483/minaris-regenerative-medicine-llc/ac4c71cd-5f2b-4894-aeda-0eaff58988ab)

## Related Officers

- [FDA_PERSONNEL](https://www.keypedia.com/people/lizaida-perez/686fbdca-bfd7-4a73-990a-d8a97e6b88b7)
- [Shafiq Ahadi](https://www.keypedia.com/people/shafiq-ahadi/593bbf28-02e6-47bb-86c3-65cbd4ec520d)

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

Office: https://www.keypedia.com/offices/fda-district-office-chicago-illinois/62c2811c-10c5-4d74-99d0-eb5047ef3b65