# FDA 483 - Trilogy Laboratories, LLC - August 27, 2019

Source: https://www.keypedia.com/records/483/trilogy-laboratories-llc/4f9670ba-7ea2-4356-8022-04efb9565596

> FDA 483 for Trilogy Laboratories, LLC on August 27, 2019. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Trilogy Laboratories, LLC
- Inspection Date: 2019-08-27
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of Trilogy Laboratories, LLC in Fort Myers, FL, revealed numerous significant cGMP deficiencies. The firm lacks a functional quality control unit, adequate laboratory controls, and proper stability data to support drug product expiration dates. Additionally, manufacturing processes are unvalidated, and batch and master production records are incomplete or absent, indicating a systemic failure to ensure the quality and purity of their topical human drug products.

## Related Documents

- [WARNING_LETTER - 2019-08-27](https://www.keypedia.com/records/warning_letter/trilogy-laboratories-llc/ae30ca41-88f8-41ef-a662-4ae79761a6b8)

## Related Officers

- [Jennifer L. Huntington](https://www.keypedia.com/people/jennifer-l-huntington/c04e1c86-c7ec-4613-b3f7-a1f9ba2b2f2c)

Company: https://www.keypedia.com/companies/trilogy-laboratories-llc/01ba4ed0-ffdc-4b59-af66-938193088a3e

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6