FDA WARNING_LETTER - Iso-Tex Diagnostics, Inc - June 02, 2010

An FDA inspection of Iso-Tex Diagnostics, Inc. from May 4 to June 2, 2010, revealed significant Current Good Manufacturing Practice (CGMP) violations, rendering their drug products adulterated.

Key violations include: 1. **Inadequate Investigations (21 C.F.R. § 211.192):** The firm failed to thoroughly investigate positive sterility test results for Glofil I-125 (lot G92006-82) and Jeanatope I-125 (lot J101702-25B). Investigations did not consider drug product contamination for Glofil I-125 and failed to determine the root cause for the retest positive result for Jeanatope I-125. 2. **Lack of Aseptic Process Validation (21 C.F.R. § 211.113(b)):** The firm has not validated the (b)(4) Filter used for sterilization of multiple drug products. Procedures for transferring the (b)(4) Air Sampler between classified areas are not established, and sanitization SOPs are deficient, lacking details for plastic totes and requiring non-sterile bleach/water. 3. **Inadequate Facility Control (21 C.F.R. § 211.42(c)(10)(i)):** Walls