Pharmedium Services, LLC – FDA 483, Jan 4, 2016

The FDA Form 483 inspection revealed significant deficiencies in the firm's drug manufacturing and quality control processes. A primary concern is that drug product containers or closures were reactive, altering the safety, identity, strength, quality, and purity of the drug. This issue, specifically related to (b)(4), led to multiple batches of finished drug products failing potency and/or purity limits between July 2014 and July 2015. Numerous lots of Fentanyl Citrate, Methadone HCl, and Atropine Sulfate in various syringe sizes were released with potency results significantly below established limits.

The firm also failed to establish a procedure for release testing of finished drug products to ensure conformance to identity and strength specifications before release. Furthermore, there is no procedure requiring sterility testing or bacterial endotoxin testing for every batch of finished drug product purporting to be sterile or non-pyrogenic, respectively. The "On-Going Sterility Monitoring Program" (CPS-775) only samples a fraction of batches.

Stability test results documenting out-of-limit potency failures were not used to evaluate the appropriateness of current expiry dating for marketed drug products. Investigations into stability failures (e.g., HHE-15-017-R1, HHE-15-020, HHE-15-023) did not consistently include documented evaluations of product expiry dating for all affected lots.

Finally, the firm lacks