FDA 483 - QuVa Pharma, Inc. - June 20, 2014

The FDA Form 483 details observations from an inspection of a facility producing human drug products intended to be sterile.

**Key Violations and Observations:**

* **Inadequate Sterility Failure Investigations:** The firm failed to thoroughly review sterility failures for five batches of sterile human drug products (N-Acetyl Cysteine 20% batches 86513 & 86514, Sodium Bicarbonate DSW batch 86535, Neostigmine batch 87100, Calcium Gluconate batch 86893) between January 27 and March 26, 2014. The Neostigmine batch also failed for endotoxin. Investigations did not extend to related batches or identify preventative actions for lab methods or environmental contaminants. * **Insufficient Non-Conformance Investigations:** Investigations of non-conformances were not fully documented or extended to related batches. Examples include an incident with particulate in Hyaluronidase vials (lot #87264) where particle identification was incomplete and a third-party analysis was not conducted, and particulate matter found in another batch (87253). Both batches were rejected. * **Deficient Microbiological Contamination Prevention Procedures:** * **Media Fills:** Aseptic process simulations (media fills) have not been executed for over 100 different sterile injectable human drug product batches produced since