FDA WARNING_LETTER - Global Protection Corp. - November 07, 2007
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On January 7, 2008, the FDA issued a Warning Letter to Global Protection Corp. following an inspection from October 31 to November 7, 2007. The inspection revealed that the firm's male condoms and related products, classified as devices, were adulterated under 21 U.S.C. § 351(h) due to non-conformity with Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 C.F.R. Part 820).
Key violations included: 1. **Failure to validate processes (21 C.F.R. § 820.75(a)):** The package seal integrity test was not validated, and the firm's interpretation of "bubble streams" not constituting a leak was deemed flawed, contrary to standard test methods. A collected sample (lot # 99007109) failed water leakage and package seam integrity tests. The firm's decision to discontinue current pouching material and seek new, validated material was noted, with a request for validation data prior to resuming production. 2. **Failure to establish finished device acceptance procedures (21 C.F.R. § 820.80(d)):** The In House Waterleak Testing Procedure (QP_19) lacked acceptance/rejection criteria. Lots 1
ID · bec92c59-c348-4fe2-8e82-da09c2266b77
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