FDA 483 - Rancho Park Compounding Pharmacy - May 07, 2019

An FDA Form 483 was issued following an inspection of a sterile compounding lab, revealing multiple deficiencies in facility design, operations, and aseptic processing.

Observations included visibly dirty equipment and surfaces in ISO 5 Laminar Flow Workstations (LAFWs), with yellowish-brown stains and spots on stainless steel surfaces, curved metal hooks, cap screws, and HEPA filter covers. Non-microbial contamination was noted in ISO 7 buffer and anterooms, including chipped ceiling material, discolored bolt screws, and dirty HEPA filter covers.

Personnel were observed blocking first-pass air during aseptic manipulations, specifically when capping sterile dropper tips for Dexamethasone Ophthalmic Soln. Non-sterile wipes were used with disinfecting agents in ISO 5 LAFWs, and materials were not properly disinfected before entering aseptic processing areas.

The facility's design included dust-collecting overhangs like wall cable raceways in ISO 7 areas that were difficult to clean. Gowning procedures were improper, with gowns touching the floor and wet spillage. Unsealed and loose ceiling tiles, including a cracked light cover and unsealed light fixture frame, were found in the ISO 7 buffer room. The gowning room's layout in the ISO 7 anteroom was deemed to permit poor flow of personnel and materials, leading to potential contamination of gowning apparel.