FDA 483 - Concord, Inc. dba Carlton's Dunwoody Pharmacy - January 13, 2016

On January 13, 2016, the FDA issued a Form 483 to Carlton's Dunwoody Pharmacy Corp, a producer of non-sterile drugs, located at 5484 Chamblee Dunwoody Rd, Dunwoody, GA. The inspection, conducted from January 5-13, 2016, by Investigators Tamara J Henderson and Rachael L Cook, revealed five observations.

Observation 1 noted the absence of a written stability testing program, leading to unsupported expiration/beyond-use dates for non-sterile drug products, with some dates exceeding those of the Active Pharmaceutical Ingredients (APIs) for Biest/Progesterone/Testosterone, Triest/Progesterone, and Budesonide capsules.

Observation 2 indicated that finished product testing was not conducted on any non-sterile drug products to ensure strength and quality prior to release.

Observation 3 highlighted that the quality control unit lacked responsibility for approving and rejecting procedures impacting drug product identity, strength, quality, and purity, specifically noting no written procedures for testing, complaint handling, recalls, cleaning, or facility/equipment maintenance.

Observation 4 stated that calibration of instruments, including a (b)(4) calibration weight and (b)(4) balances used for APIs, was not performed at suitable intervals or according to a written program, and no written procedures for their calibration existed.

Observation 5 detailed that batch production and control records,