FDA WARNING_LETTER - IsoAid, L.L.C. - April 20, 2012
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On August 16, 2012, the FDA issued a Warning Letter to IsoAid, L.L.C. following an inspection from April 12-20, 2012, which found their Advantage Iodine-125™, Advantage PD-103™ Brachytherapy Seeds, and Advantage-Strand™/Advantage-Load™ Brachytherapy Kit devices to be adulterated and misbranded.
The devices were deemed 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). Violations included: 1. **Failure to validate processes (21 C.F.R. 820.75(a)):** Specifically, the EO sterilization process, heat sealer process, and BI reader were not adequately validated. 2. **Failure to control production processes (21 C.F.R. 820.70(a)):** The sterilization procedure lacked provisions for positive BI results, and investigations into nonconformances were not documented. 3. **Failure to validate computer software (21 C.F.R. 820.70(i)):** The Sorting software for decay calculations was not validated, and procedures for qualification,
ID · 5d13b1bc-3e8b-473e-8dae-5abc9ec704ba
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