FDA WARNING_LETTER - Innolatex SDN. BHD. - January 20, 2011

On January 17-20, 2011, an FDA inspection of Innolatex SDN. BHD. in Port Klang, Malaysia, revealed that their male natural Latex Condoms and Condoms with a Spermicidal Lubricant were adulterated under 21 U.S.C. § 351(h). The manufacturing, packing, storage, or installation methods and controls did not conform to the Quality System (QS) regulation (21 CFR Part 820).

Key violations included: 1. **Process Validation (21 CFR 820.75(a))**: Failure to adequately validate the (b)(4) machine/protocol V-OQ-06-002 and the (b)(4) process for (b)(4) from condoms. The firm's response was deemed inadequate without re-validation documentation. 2. **Quality Data Analysis (21 CFR 820.100(a)(1))**: Failure to analyze quality data (e.g., visual and (b)(4) test records showing high (b)(4) and (b)(4) for specific lots) to identify causes of nonconforming product. The response was inadequate due to lack of employee training documentation for revised procedures. 3. **Nonconformity Investigation (21 CFR 820.100(a)(2))**: