FDA 483 - shiraz specialty pharmacy, inc. - June 15, 2017

The FDA Form 483 documents observations from an inspection of a facility producing highly potent, hazardous, non-hazardous, and beta-lactam containing drugs in non-sterile production areas. The primary concern is inadequate containment, segregation, and cleaning to prevent cross-contamination.

Specifically, on March 30, 2017, "Magic Mouthwash" containing penicillin was prepared in a hood also used for highly potent and non-hazardous drugs. A non-dedicated mortar and pestle, used for other drug products, was used to crush penicillin tablets. Other drugs, including Anastrozole, Progesterone, Testosterone, Tadalafil, Ranitidine, Guanfacine, and Bi-Est, were produced in the same hood and shared equipment. No testing is performed to ensure cross-contamination with beta-lactam products.

On May 31, 2017, a Pharmacy Technician's lab coat sleeves contacted spilled progesterone during production of Progesterone 200 mg capsules. The technician stated the same lab coat is used for approximately one week and is not changed between batches of various highly potent or beta-lactam containing products.

Cleaning of production areas, equipment, and utensils for highly potent and beta-lactam drugs is inadequate. The firm uses a wipe-down method with an unspecified agent, lacking data to support its effectiveness in removing and neutralizing potent drug residues. On May 31, 2017