FDA 483 - Petra Hygienic Systems Int Ltd - April 22, 2022

An FDA inspection of Petra Hygienic Systems Int Ltd, an OTC drug manufacturer in Concord, revealed significant and repeated deficiencies in their manufacturing processes. The firm lacked adequate written procedures for production, quality control, equipment cleaning, and stability testing. Furthermore, issues with microbial testing, data integrity in computer systems, and raw material identity verification were noted, with several problems being repeats from a previous inspection.