FDA WARNING_LETTER - maplerose enterprises, llc, - August 22, 2016

On August 2, 2017, the FDA issued a Warning Letter to Maple Rose Enterprises, Inc. dba Pencol Compounding Pharmacy following an inspection from August 8-22, 2016. The inspection revealed that the firm produced drug products that failed to meet Section 503A of the FDCA conditions for exemption from certain provisions, including CGMP, adequate labeling, and FDA approval.

Key violations included: - **Failure to meet 503A conditions**: The firm did not receive valid prescriptions for individually-identified patients for a portion of compounded drug products, rendering them ineligible for exemptions. - **Adulterated Drug Products (Section 501(a)(2)(A) & (B) FDCA)**: Sterile drug products were prepared under insanitary conditions. Specific observations included using non-sterile cleaning agents on ISO 5 surfaces, insufficient sporicidal agent contact time, a gap in the ceiling tile above the aseptic production area, failure to perform post-filtration integrity testing, and inadequate demonstration of hood protection for ISO 5 areas. Additionally, significant CGMP violations were noted for ineligible drug products, such as failing to establish and follow procedures to prevent microbiological contamination (21 CFR 211.113(b)), inadequate cleaning and disinfection systems (21 CFR 211.42(c)(10)(v)), inappropriate personnel clothing (21 CFR