FDA 483 - Keystone Rx LLC - July 12, 2019

On July 12, 2019, the FDA issued a Form 483 to Keystone Rx LLC, a producer of non-sterile drug products located at 3070 Bristol Pike, Building 2, Suite 216-b, Bensalem, PA 19020-5364. The inspection, conducted from July 8-12, 2019, identified Ms. Deepa Jacob, Pharmacist In Charge, as the individual to whom the report was issued.

The sole observation noted was non-microbial contamination in the production area. Specifically, on July 9, 2019, after producing Rx (b)(6) 1, 5% Flurbiprofen/ 2% Cyclobenzaprine/ 5% Lidocaine cream, and subsequent cleaning, the following were observed: apparent dried powder residue (yellow and white) in approximately 13 grate holes of the biological safety cabinet, apparent white powder residue on the hood's processing surface (identified as Flurbiprofen spillage), smeared residue immediately in front of the grate, and yellow staining on scale (b)(4) inside the hood, which is used for weighing raw materials. This indicates deficiencies in cleaning and contamination control procedures within the manufacturing environment.