FDA WARNING_LETTER - Aplicare, Inc. - January 15, 2016

The FDA issued a Warning Letter to Aplicare, Inc. following an inspection from December 14, 2015, to January 15, 2016, identifying significant CGMP violations for finished pharmaceuticals, rendering their drug products adulterated.

Key violations include: 1. **Inadequate Microbiological Controls for Sterile Products (21 CFR 211.113(b))**: Aplicare failed to validate its "sterilization" process for povidone-iodine products, using an unsuitable biological indicator and repeatedly isolating spore-forming microorganisms since 2012. The firm's proposed revalidation plan was deemed inadequate due to past failures and insufficient scientific justification for sterility assurance. 2. **Inappropriate Air Filtration Systems (21 CFR 211.46(c))**: Povidone-iodine products, purporting to be sterile, were manufactured in unclassified areas, lacking appropriate air cleanliness and HEPA filtration. 3. **Insufficient Environmental Control Systems (21 CFR 211.42(c))**: Environmental monitoring was inadequate, with Bacillus species repeatedly isolated. The revised monitoring procedure lacked scientific rationale for limits, permitted high air contamination, and had an insufficient organism identification program. 4. **Failure to Assess Stability for Sterility (21 CFR 211.166(a))**: Stability studies for povidone-iodine products did not include