FDA 483 - Custom RX LLC, dba Custom RX Compounding Pharmacy - August 28, 2014

The FDA inspection of a drug manufacturing facility revealed multiple violations related to the production of penicillin and other drug products. The facility uses non-dedicated space and equipment for penicillin antibiotics (Amoxicillin, Clavulanic Acid, Ampicillin products) produced between 1/1/2013 and 8/19/2014, in the same areas as other human/animal drug products. There are no specific procedures for penicillin production, including cleaning, residue elimination, powder handling, or equipment use.

The production area, used for Methylene Blue Solution, Amphotericin Lozapressure Capsule for Inhalation, Gentamicin Lozapressure Capsule for Inhalation, Clomarbutil, hormone-containing, and thyroid-containing products, was not maintained in a clean and sanitary condition. Observations on 8/11 & 8/19/2014 included dust, powder, and debris on a non-classified ventilation hood, tape with residue on an encapsulation hood and capsule machine, powder and rust on scales, unlabeled cleaning solutions, discolored plastic molds, worn vacuum equipment, scratched plastic scrapers, and a dust-covered keyboard.

For Methylene Blue Solution (Lot 07082014:65@20), in-process materials are not tested for identity, strength, quality, and purity. The firm lacks documentation for its intended use, has not established in-process specifications consistent with