FDA 483 - RC Outsourcing, LLC - February 08, 2019

The FDA Form 483 details multiple violations at a drug manufacturing facility. The firm failed to follow written production and process control procedures, specifically for Vancomycin HCl USP 1mg/0.1ml lot no. 03092018, where the reported pH of 6.97 was outside the specified range of (b)(4). This high pH led to vancomycin precipitation and two complaints of cloudiness. The firm's Quality review failed to detect this out-of-specification (OOS) pH prior to lot release, and adequate CAPAs were not implemented.

A written testing program for assessing drug product stability characteristics is absent, and the firm lacks adequate data (published literature or test studies) to support product Beyond Use Dates (BUDs)/Expiration dates. The firm also failed to investigate 70 syringe defect complaints received between April 2017 and December 2018, covering issues like bent/dull/clogged needles, stuck plungers, and empty syringes.

Testing and release of drug products for distribution are deficient. Identity and strength (potency) testing was not performed for Cefuroxime 1mg, Moxifloxacin 1.5mg, Vancomycin 1mg, and Vancomycin 2mg. pH testing was not performed for Cefuroxime 1mg. Subvisible particulate testing was not performed for Cefurox