FDA 483 - QuVa Pharma, Inc. - June 16, 2022

From June 7-16, 2022, the FDA inspected QuVa Pharma, Inc., an outsourcing facility located at 5920 S General Bruce Dr Ste 100, Temple, TX 76502-5804. The inspection revealed four observations.

Observation 1 noted deficiencies in aseptic processing areas, specifically a propagating crack in the epoxy flooring of the ISO 7 Cleanroom, exposing the base material. This condition could hinder cleaning and disinfection and potentially harbor microbial contamination. The firm's PIC was unaware of this issue.

Observation 2 identified that input and output data for computer records were not checked for accuracy. The firm used an unvalidated online software, 'b(4)', to determine drug product Beyond Use Dates (BUDs) on bulk drug finished product labeling. The Quality Manager confirmed the software's accuracy had not been verified, and its use predated the acquisition.

Observation 3 detailed deficiencies in master production and control records. A. Batch records for Ephedrine Sulfate bulk concentrates failed to include instructions and documentation for placing non-sterile bulk concentrate bags into a 'b(4)' bag to prevent light penetration and potential product degradation. The quality manager cited this as an oversight. B. The firm's procedure TEM-WI-PO-009, "Labeling Preparations," inadequately documented 'b(4)' bag requirements for bulk drug concentrate packing and labeling,