FDA 483 - Westlab Pharmacy, Inc. dba Westlab Pharmacy - August 15, 2018

The FDA Form 483 documents observations from an inspection conducted between May 14, 2018, and August 14, 2018, identifying multiple deficiencies in the facility's operations and quality system.

A critical finding was the location of an ISO 5 classified aseptic processing area, specifically a (b)(4) used for mitomycin and cyclosporine drug products, within a non-classified room. This area produced several lots of Mitomycin Opht 0.02% and Cyclosporin Aqueous 0.5% and 1% solutions.

Further observations included the use of non-sterile disinfecting agents and cleaning wipes in ISO 5 classified aseptic processing areas. On August 6, 2018, during a media fill, non-sterile wipes were used to clean the ISO 5 Laminar Airflow Workstation (LAFW) and were maintained in the ISO 7 clean room. Other non-sterile products, (b)(4), (b)(4), and (b)(4), were also used for cleaning.

The firm used non-pharmaceutical grade (b)(4) in the production of Alprostadil 500mcg/mL injectable (Lots 03182018@42 and 07252018@17) and other non-sterile products, including Vancomycin/Water 250