FDA WARNING_LETTER - Braintree Laboratories Inc - January 22, 2010

The FDA issued a Warning Letter to Braintree Laboratories, Inc. following a December 2009 – January 2010 inspection, identifying significant Current Good Manufacturing Practice (CGMP) violations, rendering their drug products adulterated. The firm's February and March 2010 responses were deemed insufficient.

Key violations include: 1. **Inadequate Investigations of Out-of-Specification (OOS) Results and Complaints (21 CFR § 211.192):** * **Foreign Material Complaints:** 21 consumer complaints (2008-2009) cited foreign materials (insects, spiders) in five products. The firm concluded the material wasn't from their manufacturing but failed to thoroughly investigate facility or raw material sources. While committing to increased pest control, complaint trend review, and foreign matter identification, the FDA requires a plan for additional source determination and supplier audits. * **PhosLo Gel caps (Lot 1308016) Dissolution Failures:** Accelerated stability samples failed dissolution specifications at 2, 3, and 6 months. The firm inappropriately invalidated results and used an unapproved dissolution medium ((b)(4)) without proper investigation, a significant deviation from the NDA requiring a prior approval supplement. The firm released this lot despite 6-month failing results. The FDA disagreed with the firm's conclusion that inner caplet and