FDA 483 - Crosbys Drugs Inc - September 16, 2016

This FDA Form 483, issued to Sherrie L. Cohen-Merchant, Owner of Crosbys Drugs Inc, a producer of sterile drugs located at 2609 N High St, Columbus, OH, was conducted from September 12-16, 2016. The inspection revealed eight observations concerning the facility's sterile drug production.

Observation 1 noted a lack of established and followed procedures to prevent microbiological contamination, citing an employee touching an uncovered container with bare hands during Tri-Mix production, absence of smoke studies for the ISO 5 hood, and no data for process simulation tests.

Observation 2 indicated that personnel clothing was inappropriate, with non-sterile gowns and face coverings being reused multiple times.

Observation 3 stated that drug product containers and closures were not properly cleaned and sterilized to remove pyrogenic properties, specifically mentioning equipment cleaned with non-depyrogenated methods.

Observation 4 highlighted that the flow of components and in-process materials was not designed to prevent contamination, as equipment was not disinfected when moved between clean rooms.

Observation 5 detailed deficiencies in environmental monitoring within aseptic processing areas, including infrequent particulate and viable air sampling, infrequent fingertip plating, and lack of historical monitoring data.

Observation 6 found that container closure systems lacked data to support protection against external factors, specifically for alprostadil containers.

Observation 7 reported that sterile and pyrogen-free drug products, including Tri-