FDA WARNING_LETTER - Laglove Sdn Bhd (M) aka LA Glove - September 09, 2010

On September 6-9, 2010, an FDA inspection of Laglove Sdn Bhd (M) aka LA Glove in Selangor D.E., Malaysia, revealed that their FC2 Female Condoms, classified as devices, were adulterated. The manufacturing, packing, storage, or installation methods and controls did not conform to the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820).

Violations included: 1. Failure to establish and maintain adequate equipment maintenance schedules and documentation (21 CFR 820.70(g)(1)), exemplified by undocumented non-scheduled coagulation tank cleanings and an unrepaired dryer machine timer. 2. Failure to ensure inspection, measuring, and test equipment suitability (21 CFR 820.72(a)), shown by an employee using a personal cell phone alarm for mixing times due to a broken clock. 3. Failure to adequately control environmental conditions (21 CFR 820.70(c)), evidenced by dust and particulate matter near open tanks and ovens. 4. Failure to adequately evaluate and select suppliers (21 CFR 820.50(a)(1)), as the purchasing procedure lacked clear supplier evaluation criteria. 5. Failure to establish and maintain adequate procedures for product identification (21 CFR 820.60), observed with un