FDA Warns Compounder Over Unsterile Procedures, GMP Failures

The FDA sent a warning letter to Ranier’s Compounding Laboratory, based in Jeannette, Pa., noting serious deficiencies in sterile procedures and GMPs.

The agency initially issued a Form 483 after an April 2016 inspection, but was not satisfied with the response. FDA investigators said Ranier’s did not receive valid prescriptions for individually-identified patients for a portion of the products, and produced drug products in violation of the FDCA.

The firm said it would cease compounding office-use-only products for physicians, but the FDA said it was unable to fully evaluate the corrective actions because of a lack of supporting documentation.

Investigators also noted that sterile drug products were prepared, packed or held under insanitary conditions: aseptic operators placed their ungloved hands into the ISO 5 hood, and failed to sanitize their gloved hands after touching non-sterile components.

Additionally, non-sterile wipes were used in the hood, and sterile water was placed in non-sterile spray bottles used to clean equipment. Meanwhile, components were not disinfected during transfer from the ISO 6 compounding room to the ISO 5 hood.

The firm also failed to establish written procedures to prevent microbiological contamination, lacked monitoring environmental conditions in aseptic processing areas, and failed to design the facility with separated areas necessary to prevent “contamination or mix-ups,” the FDA said.

The checklist is designed for internal audits — to prepare staff to answer investigator questions — and to spot and correct mistakes before the investigators ever arrive. GMP Inspection Preparation Checklist: A Tool for Internal Auditing includes more than 650 items organized in three sections covering all aspects of quality manufacturing. Order your copy today.