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

Source: https://www.keypedia.com/records/warning_letter/jiangsu-province-jianerkang-medical-dressing-co/25eec2b6-5d81-4529-a0e6-a19758e753b2

> FDA WARNING_LETTER for Jiangsu Province Jianerkang Medical Dressing Co. on September 19, 2011. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Jiangsu Province Jianerkang Medical Dressing Co.
- Inspection Date: 2011-09-19
- Product Type: Drugs
- Office Name: Department of Health and Human Services
- Summary: 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

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