FDA 483 - Bayview Pharmacy, Inc. - August 18, 2016

The FDA Form 483 inspection revealed multiple violations concerning aseptic processing, environmental control, and cross-contamination prevention. Personnel were observed blocking first-pass air in the ISO 5 zone, reaching into the Laminar Flow Hood with non-sterile attire (frock, dust mask, hair cover exposing face/eyes), and compromising sterility by placing vial stoppers face-down on a wipe. On 08/09/2016 and 08/10/2016, a pharmacist's upper body and head broke the ISO 5 plane during aseptic filling of Acetylcysteine 10% (PF) Nebulizer INH SOLN (Lot # 08082016@10) and TRI-MIX, leading to lot discards. Logged Formula Worksheets were placed in the ISO 5 hood, potentially disrupting airflow, also resulting in lot discards for Acetylcysteine and TRI-MIX.

The ISO 7 Cleanroom temperature reached 79°F on 08/09/2016, causing visible perspiration, with logs showing temperatures exceeding 78°F on twelve days (May 2016-present), peaking at 81°F. Facility design allowed poor quality air into higher classified areas, and no dynamic airflow assessment existed for the ISO 5 hood.

Highly potent drugs, including hormones (progesterone, estradiol