FDA 483 - QuVa Pharma, Inc. - November 30, 2017

This FDA Form 483 document details observations from an inspection, citing deficiencies in sanitation procedures and batch production records. The facility's written procedures for sanitation, specifically SOP NJ-SOP-SA-0003, Section 4.4, were not followed. This SOP requires (b)(4) cleaning of Aseptic Processing Areas (cleanrooms and gowning/ante-rooms) (b)(4) when (b)(4) is used for production activities. However, the (b)(4) cleaning log for ISO-7 cleanroom (b)(4) lacked documentation of cleaning for Heparin 1unit/mL 3L Bulk, Lot (b)(4), which had a compounding date of 10/25/17.

Furthermore, the batch production and control records were found to be deficient. They were not an accurate reproduction of the appropriate master production or control record, nor were they checked for accuracy, dated, and signed as required. These observations indicate issues within the facility's quality system regarding adherence to established sanitation protocols and the integrity of manufacturing documentation. The implications include potential risks to product quality and sterility due to inadequate cleanroom maintenance and a lack of proper record-keeping for production batches.