FDA 483 - ImprimisRx NJ - July 10, 2017

This FDA Form 483 document details inspectional observations made at ImprimisRx NJ, located at 1705 Route 46 West, Suite 6A, Ledgewood, NJ 07852-9720. The firm, FEI number 3003348498, is identified as a producer of sterile drugs. The inspection was conducted on May 30, 31, June 1, 2, and July 10, 2017. The report was issued to Pramod K Sharma, Ph.D, Vice President, Quality, on July 10, 2017, by Consumer Safety Officer Jose M. Cayuela.

The sole observation noted was that the ISO 5 laminar air flow hood was not certified under dynamic conditions. Specifically, the smoke study performed in a section of the ISO 5 laminar air flow hood was not conducted with all personnel and containers present. The study used (b)(4) instead of (b)(4), lacked a bulk container, and (b)(4) did not simulate product filling during the (b)(4) video, failing to assess uni-directional air flow under actual operating conditions. This indicates a deficiency in the validation and control of critical aseptic processing environments.