FDAnews Drug Daily Bulletin

FDA Finds Repeat Deficiencies at Ohio Outsourcer

May 22, 2017

The FDA hit an Ohio outsourcing facility with an extensive Form 483, listing failures to adhere to GMP and overall sterility, cleaning and quality control issues—with several problems repeated from an inspection a year before.

Of 22 contaminated product samples recorded between Feb. 14 and March 10 from repackaging and compounding shop RC Outsourcing in Lowellville, Ohio, only five investigations were completed, two of which resulted in additional cleaning and in only one instance was the colony-forming organism identified, according to investigators.

The contaminated sample problem found during the March 2017 visit was previously noted in a February 2016 FDA inspection, according to the Form 483.

Other repeat problems included a lack of written procedures for preventing microbiological contamination of drug products and a lack of proper air and particulate monitoring.

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