Pax-All Manufacturing Inc. – FDA Warning Letter, Sep 23, 2011

The FDA issued a Warning Letter to Pax-All Manufacturing Inc. on March 9, 2012, following a September 19-23, 2011 inspection. The inspection revealed significant Current Good Manufacturing Practice (CGMP) violations, rendering their drug products adulterated.

Key violations include: 1. **Lack of Product Testing:** Failure to perform in-process and finished product testing for drug products, with approximately (b)(4) batches distributed to the U.S. between September 2009 and September 2011 lacking finished product testing. 2. **No Stability Program:** Absence of a written stability testing program to determine storage conditions and expiration dates for products like (b)(4) and (b)(4), and insufficient data for others. 3. **Labeling and Packaging Control Failures:** Failure to follow procedures ensuring correct labels and packaging, including lack of traceability for formulation lots and packaging materials in batch records, and incorrect lot numbers on some finished products. 4. **Inadequate Equipment Design:** Use of unsuitable materials (tape, cardboard) for repairs on Filling Line (b)(4), compromising cleanliness and suitability for drug manufacturing. 5. **Insufficient Equipment Cleaning:** Lack of documented cleaning procedures, cleaning records, and cleaning validation for multi-use equipment.

The FDA also noted deficiencies questioning the effectiveness of the firm's quality system and highlighted that Pax-All