FDA WARNING_LETTER - Jiangsu Province Jianerkang Medical Dressing Co. - September 19, 2011

The FDA issued a Warning Letter to Jiangsu Province Jianerkang Medical Dressing Co., Ltd. on July 30, 2012, following a September 13-19, 2011 inspection. The inspection revealed significant Current Good Manufacturing Practice (CGMP) violations, rendering their drug products adulterated.

Key violations include: 1. **Failure to prevent objectionable microorganisms in non-sterile drug products (21 CFR § 211.113(a))**: FDA testing of Zee Antiseptic Wipes found *Burkholderia cepacia*, *Staphylococcus intermedius*, *Staphylococcus sciuri*, and *Burkholderia pseudomallei*. The letter requested the source of contamination, a list of impacted products, test results, validated test methods, and a risk assessment. 2. **Inadequate validation of sterilization processes (21 CFR § 211.113(b))**: The sterilization process for Povidone-Iodine Gel Swab Sticks was deemed inadequately designed and lacked proper biological indicator studies. The FDA requested an evaluation of the sterilization method and a revised validation protocol. 3. **Failure to thoroughly investigate batch failures (21 CFR § 211.192)**: The firm's investigation into out-of-specification sterilization temperatures for Povidone-Iodine Gel Swab Sticks was incomplete, failing to identify instances where temperatures