FDA 483 - ACRX Specialty Pharmacy Inc - March 20, 2019

ACRX Specialty Pharmacy Inc. in Las Vegas, NV, was inspected for its production of sterile and non-sterile drug products. The inspection revealed significant deficiencies across multiple areas, including inadequate procedures for preventing microbiological contamination, insufficient environmental monitoring, and a lack of stability and product testing. These issues indicate a broad lack of control over critical aspects of drug manufacturing and quality assurance.