FDA 483 - Maple Rose Enterprises, Inc, dba Pencol Pharmacy - February 26, 2019

This FDA Form 483, issued to Maple Rose Enterprises, Inc. dba Pencol Pharmacy, a producer of sterile and non-sterile drugs in Denver, CO, following an inspection from February 11-26, 2019, details eleven observations.

**Laboratory System:** * **Observation 1:** Sterile and pyrogen-free drug products are not laboratory tested for conformance. Intrathecal products lack sterility and endotoxin assurance, with no pre-distribution data. Sterility monitoring via (b)(4) is unvalidated, and media lacks growth promotion testing. Non-sterile starting materials are used for these preparations.

**Facilities and Equipment System:** * **Observation 2:** Buildings are not maintained in good repair. The ante room and clean rooms (ISO 5, ISO 7) show a 1.5x0.5-inch dent in sheetrock, unclean sprinkler heads, and rust-like spots on handles/hinges. HEPA filters in the ante room lack functionality indication. This is a repeat observation from August 22, 2016. * **Observation 3:** Routine calibration of mechanical and electronic equipment is not performed. Temperature, humidity, and pressure monitoring equipment (including (b)(4) door monitoring and magnehelic gauge) have never been calibrated. Calibration data is lacking for the (b)(4) gauge used for (b)(4)