# FDA 483 - Aphena Pharma Solutions - Tennessee LLC - November 16, 2017

Source: https://www.keypedia.com/records/483/aphena-pharma-solutions-tennessee-llc/f11108da-6e65-47d7-88f4-a035e46e5a5b

> FDA 483 for Aphena Pharma Solutions - Tennessee LLC on November 16, 2017. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Aphena Pharma Solutions - Tennessee LLC
- Inspection Date: 2017-11-16
- Product Type: drugs
- Office Name: New Orleans District Office
- Summary: An FDA inspection of Aphena Pharma Solutions-Tennessee, LLC in Cookeville, TN, a drug packager, revealed significant deficiencies in quality control unit procedures, including inadequate investigations and failure to address environmental excursions. The firm also lacked written procedures for critical production and process controls, and its facility had deficient areas for preventing contamination and mix-ups during packaging operations.

## Related Documents

- [483 - 2013-12-12](https://www.keypedia.com/records/483/aphena-pharma-solutions-tennessee-llc/ff15f097-1a65-4476-9dd2-642e2b854949)
- [EIR - 2022-07-22](https://www.keypedia.com/records/eir/aphena-pharma-solutions-tennessee-llc/5aa217d6-343e-432f-a40d-90d52ecaf703)

## Related Officers

- [Brandon C. Heitmeier](https://www.keypedia.com/people/brandon-c-heitmeier/09e1b64b-01de-4f8b-819a-1179d8b4c0c1)

Company: https://www.keypedia.com/companies/aphena-pharma-solutions-tennessee-llc/69de5617-e85d-4684-a5af-8c1ceb15bb7f

Office: https://www.keypedia.com/offices/new-orleans-district-office/95352142-b992-4e06-849d-d7483c0959ea