FDA WARNING_LETTER - Xylo Chem Industries - July 16, 2001

On November 15, 2011, the FDA issued a Warning Letter to Xylo Chem Industries following a July 11-16, 2011 inspection of their API manufacturing facility in Nadiad, India. The inspection revealed significant deviations from Current Good Manufacturing Practice (CGMP), rendering their APIs adulterated under 21 U.S.C. § 351(a)(2)(B).

Key violations included: 1. **Incomplete Batch Production Records:** "Manufacturing Report" documentation lacked specific instructions, process parameter results, deviations, and release testing results. The firm's response to revise records and SOPs by May 25, 2012, was deemed inadequate for failing to describe control measures during the update process, specific instructions to be added, and a justification for the prolonged deficient practice. 2. **Incomplete Laboratory Control Records:** Laboratory notebooks lacked fundamental quality control data, including raw data, calculation records, and documented second-person review. The firm's response to implement a tracking system and update SOPs by May 25, 2012, was insufficient, requiring a list of specific SOPs/records, a retrospective evaluation of missing data's impact, and details on implementation dates and training. 3. **Unsupported API Expiry/Retest Dates:** The firm lacked stability data to support a (b)(4) year re