FDA WARNING_LETTER - Izeen Pharma Inc - July 03, 2018

The FDA issued a Warning Letter to Izeen Pharma Inc. following a June-July 2018 inspection, citing significant CGMP violations for finished pharmaceuticals, rendering their drug products, specifically levothyroxine and liothyronine (thyroid tablets), adulterated and misbranded.

Key violations include: 1. **Inadequate OOS Investigations:** Failure to thoroughly investigate out-of-specification (OOS) results for thyroid powder API and finished thyroid tablets, leading to invalidation of OOS results without scientific justification and insufficient root cause analysis for product complaints (e.g., tablet size variation, brittleness). 2. **Deficient Production and Process Controls:** Failure to establish adequate written procedures for process control, indicating a lack of an ongoing program to ensure stable manufacturing and consistent drug quality. 3. **Insufficient Laboratory Controls:** Failure to establish scientifically sound specifications and test procedures. The firm incorrectly used weight variation instead of content uniformity for thyroid tablets, which contain microgram levels of active ingredients. 4. **Inadequate Stability Program:** Deficiencies in the stability program, including failure to test for microbial content and disintegration, and not including process validation lots after significant formulation and equipment changes. 5. **Poor Computer System Controls and Data Integrity:** Lack of appropriate controls over laboratory computer systems, allowing shared usernames/passwords, administrator rights for data deletion/modification, and acknowledged incorrect data calculations leading to OOS results for released products.

The FDA also noted