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

During an FDA inspection from February 11-26, 2019, Maple Rose Enterprises, Inc. dba Pencol Pharmacy, a producer of sterile and non-sterile drugs located in Denver, CO, received a Form 483 with multiple observations.

**Laboratory System:** * **Observation 1:** The firm failed to laboratory test each batch of drug product purporting to be sterile and pyrogen-free to determine conformance. Specifically, there was no assurance of sterility and endotoxin levels for intrathecal drug products, and sterility monitoring practices were not validated or subjected to growth promotion. These products were made using non-sterile starting materials.

**Facilities and Equipment System:** * **Observation 2:** Buildings used in drug product processing were not maintained in a good state of repair. Issues included a 1.5 x 0.5-inch dent in the wall of the cleanroom, unclean sprinkler heads in ISO 7 buffer rooms and the ante room, rust-like spots on handles and hinges in the anteroom and Cleanroom 2, and no indication of functionality for HEPA filters in the ante room ceiling. This is a repeat observation from an August 22, 2016 inspection.

**Quality System:** * **Observation 7:** Responsibilities and procedures for the quality control unit were not in writing. The firm used contractor-provided SOPs that were not tailored to their specific operations