US Compounding Inc — FDA 483 Findings

Repo1ts of analysis from component suppliers are accepted in lieu of testing each component for confo1mity with all appropriate written specifications, without perfo1ming at least one specific identity test on each component and establishing the reliability of the supplier's analyses through appropriate validation of the supplier's test results at appropriate intervals.

Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include validation of the aseptic and sterilization process.

The labels of your outsourcing facility's chug products are deficient.

The quality control unit lacks the responsibility and authority to approve and reject all components, chug product containers, closures and chug products.

Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions.

Aseptic processing areas are deficient in that ceilings are not smooth and/or hard surfaces that are easily cleanable.

The written stability program for drug products does not include reliable, meaningful and specific test methods.

Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written and followed.

There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.

Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.