FDA 483 - Ranier's Rx laboratory, Inc. - August 16, 2021

On August 16, 2021, the FDA issued a Form 483 to Ranier's Rx Laboratory, Inc., a non-sterile drug manufacturer located at 1107 Lowry Ave., Jeannette, PA. The inspection, conducted from August 4 to August 16, 2021, by Consumer Safety Officer Jazmine N. Still, identified one observation.

The observation noted the presence of vermin in the production area. Specifically, on August 6, 2021, the inspector observed six ceiling lights in the general compounding lab and one ceiling light in the hallway to the hazardous compounding room containing two to twelve apparent dead insects. Additionally, a cracked ceiling light was observed approximately 24 inches directly above hood B(4) in the general compounding lab, and a 0.25-inch gap was noted in the ceiling light within the hazardous compounding room.

During the inspection on August 6, 2021, various non-sterile products were being manufactured, including Aluminum Hydroxide suspension, ABH gel, Biest/Testosterone cream, BMX Mouthwash suspension, Guanfacine suspension, Progesterone capsules, Vancomycin solution, and Gabapentin (VET) suspension. This observation indicates potential insanitary conditions where drugs may have become contaminated with filth, as per Section 704(b) of the Federal Food, Drug and Cosmetic Act.