# FDA 483 - Anesis Life, LLC - January 29, 2026

Source: https://www.keypedia.com/records/483/anesis-life-llc/f277b350-0ae6-4181-b0d7-6c11a63f066a

> FDA 483 for Anesis Life, LLC on January 29, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Anesis Life, LLC
- Inspection Date: 2026-01-29
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: Anesis Life, LLC, a drug substance manufacturer in Macomb, MI, was cited with seven observations during an FDA inspection. The inspection revealed significant deficiencies in quality unit oversight, including inadequate supplier evaluation, release of out-of-specification API products, incomplete batch records, lack of process and cleaning validation, insufficient employee training, and poor complaint handling. These issues indicate a systemic failure to adhere to CGMP principles in the manufacturing and control of active pharmaceutical ingredients and homeopathic drug products.

## Related Officers

- [investigator](https://www.keypedia.com/people/gabriel-bermudez-picart/3263ce6e-a27d-4d4b-953c-4477c17aa182)
- [Ramia Brzenjy](https://www.keypedia.com/people/ramia-brzenjy/b0e5e3b0-c295-4ec6-845a-95968824c16a)
- [Nicholas J. Presto](https://www.keypedia.com/people/nicholas-j-presto/2ecdd573-6662-4d07-b93c-ddb9c603bcfa)

Company: https://www.keypedia.com/companies/anesis-life-llc/670e5eb4-58c8-4343-be4c-5154de358b08

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0