FDA 483 - Metro Drugs 3rd Avenue Corp - April 05, 2019

From March 14, 2019, to April 5, 2019, the FDA inspected Metro Drugs 3rd Avenue Corp, a producer of sterile and non-sterile drug products located at 931 Lexington Ave, New York, NY 10065-5771. The inspection, documented in FEI number 3011795133, identified five observations.

Observation 1 noted the use of non-sterile disinfecting agents and wipes in the ISO 5 aseptic processing area. An aseptic operator was observed using non-sterile wipes to disinfect an ISO 5 laminar flow hood and as a placemat for sterile items during aseptic filling.

Observation 2 detailed the release of drug products with out-of-specification potency results. Examples included Liothyronine Sodium (T3) capsules with potencies ranging from 75.0% to 116%, Estriol/DHEA/Testosterone/Pregnenolone with DHEA at 81.3%, Estriol at 77.2%, and Testosterone at 84.5%, Methylcobalamin injectable at 53.3%, and Tri-Mix Quad and Atropine 0.1% Stock Solution with Atropine Sulfate Monohydrate potencies of 134.51% and 107.38% respectively. No product impact assessment was conducted for