ImprimisRx NJ — FDA Warning Letter Findings

Your firm failed to perform adequate smoke studies under dynamic conditions to demonstrate unidirectional airflow within the ISO 5 area. Therefore, your products intended to be sterile are produced in an environment that may not provide adequate protection against the risk of contamination.

We acknowledge your response to Observation 5 of the Form FDA 483 which indicated that a work order was initiated to investigate and remediate the issue of the gap between the sprinkler heads and the ceiling located in the ISO 7 classified filling room and your response to Observation 6 on the Form FDA 483, where you stated that the fire extinguishing sprinkler system heads were repaired to stay flush with the ceiling. However, you did not provide evidence of the repair. Your response did not include an impact assessment of the lots produced during this timeframe. Furthermore, you did not provide evidence to substantiate the claims made by the maintenance technician, who repaired the units, that the unclassified air above the ceiling did not flow into the ISO 7 classified filling room. Moreover, you did not provide supporting documentation that the rubber gaskets were in place.

Your firm did not disinfect materials during transfer from the ISO 7 cleanroom into the ISO 5 hood. Under section 301(a) of the FDCA [21 U.S.C. § 331(a)], the introduction or delivery for introduction into interstate commerce of any drug that is adulterated is a prohibited act. Further, it is a prohibited act under section 301(k) of the FDCA [21 U.S.C. § 331(k)] to do any act with respect to a drug, if such act is done while the drug is held for sale after shipment in…

An operator placed their gloved hands outside the ISO 5 work area to retrieve supplies without sanitizing their gloved hands before re-entry into the ISO 5 hood.

Your facility is designed and operated in a way that may permit the influx of lesser quality air into a higher quality air area.

We acknowledge your response to Observation 9 of the Form FDA 483 where you stated that the smoke studies were redone. However, we cannot fully evaluate your response as you did not provide sufficient supporting documentation, such as an updated smoke study protocol, an updated detailed report, and/or videos. Please be aware that section 501(a)(2)(A) of the FDCA concerning insanitary conditions applies regardless of whether drug products you compound meet the conditions of section 503A. FDA strongly recommends that your management undertake a comprehensive assessment of operations, including facility design, procedures, personnel, processes, maintenance, materials, and systems. In particular, this review should assess your aseptic processing operations. A third party consultant with relevant sterile drug processing expertise should assist you in conducting this comprehensive evaluation. D.

Your cleanroom contained fiber-like particles hanging from the ceiling as well as ceiling tiles with peeling caulking.

One of your ISO 5 classified aseptic processing areas contained HEPA filters that were stained.

We acknowledge your response to Observation 1 of the Form FDA 483, where you stated that the HEPA filter was replaced. However, you did not provide evidence that the ISO 5 hood was recertified after the work order was completed nor evidence that the smoke studies were redone after the work order was completed. Furthermore, you did not provide supporting documentation regarding the replacement HEPA filter for the FDA to fully evaluate your response.