FDAnews Drug Daily Bulletin

FDA Warns Compounder Over Unsterile Procedures, GMP Failures

June 13, 2017

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 unsanitary conditions: aseptic operators placed their ungloved hands into the ISO 5 hood and failed to sanitize their gloved hands after touching non-sterile components.

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