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

The FDA Form 483 details multiple deficiencies at a drug manufacturing facility.

**Violations and Observations:**

* **Failure to follow written procedures:** * Vancomycin HCl USP 1mg/0.1ml lot no. 03092018 had a reported pH of 6.97, exceeding the specified (b)(4) range. This OOS pH was linked to two complaints of cloudiness due to vancomycin precipitation. * The firm's Quality review failed to identify this pH OOS event before lot release. * Inadequate CAPAs were implemented to address the Quality unit's failure to observe the OOS event. * **Lack of a written stability testing program:** * No adequate data (published literature or test studies) supports the BUD/Expiration dates for products. * **Failure to thoroughly investigate discrepancies:** * No investigation was conducted for 70 syringe defect complaints (bent/dull/clogged needles, stuck plungers, empty syringes) received between April 1, 2017, and December 31, 2018. * **Inadequate drug product testing and release:** * Identity and strength (potency) testing was not performed for each lot of Cefuroxime 1mg, Moxifloxacin 1.5mg