FDA 483 - THE COMPOUNDING SHOP, INC. - September 03, 2013

This FDA Form 483 document outlines observations from an inspection of a facility producing nasal preparations containing budesonide or budesonide plus another drug substance, including irrigation solutions and sprays.

The first observation notes a failure to thoroughly review unexplained discrepancies and out-of-specification batches. Specifically, the firm did not investigate the root cause for patient-reported problems with budesonide nasal preparations, such as cloudy solutions, precipitate, or floating matter. Product returns were discarded without investigation into the cause or impact on other batches.

Secondly, complaint records are deficient, lacking investigation findings and follow-up. The firm received approximately 3-6 complaints and an unknown number of product returns regarding the physical appearance of budesonide nasal irrigation solutions within the last six months, but these were not investigated for root cause, preventing verification of complaint details.

Thirdly, each batch of drug product required to be free of objectionable microorganisms is not tested. The firm has not established microbiological acceptance criteria and lacks micro test data to demonstrate microbial quality control for its budesonide nasal preparations. Firm personnel confirmed no micro testing is conducted on nasal solutions.

Finally, there is no written testing program to assess drug product stability characteristics. The firm lacks documentation for budesonide nasal irrigation products to support microbiological quality maintenance throughout the expiration period, including antimicrobial preservative effectiveness testing. Prescription labels for budesonide nasal solution products indicate a 90-day discard period (or 30 days after opening) without supporting