Innoveix Pharmaceuticals Inc — FDA Warning Letter Findings

Your firm used a (b)(4) that is not part of a sanitation or sterilization process. The (b)(4) is not routinely cleaned and disinfected prior to use. The (b)(4) is not protected from contamination by (b)(4) on (b)(4) .

Your firm acknowledged the Pharmacist in Charge (PIC) briefly blocked first air by placing their gloves over sterile vials and stated less than five vials were impacted. These vials were not discarded and were used to prepare Sermorelin/Ipamorelin 3mg Injectable lot SIP225. Your firm stated the PIC is familiar with proper aseptic technique and reverted to correct aseptic technique after being notified during the inspection. No additional corrective actions were provided to prevent future lapses of aseptic technique from occurring.

Your firm stated that the (b)(4) cycle is self-cleaning as it is designed to eliminate any microbes that may exist therefore sterilizing itself. The Agency is not aware of any evidence to support that (b)(4) cycles is equivalent to a sterilization cycle inside the (b)(4) chamber. Your firm stated that once the (b)(4) cycle is complete, the PIC cleans the interior of the (b)(4) chamber with sterile (b)(4) wipes under ISO 5 conditions while wearing sterile garb. Your firm also stated that moving forward, a detergent and sporicidal agent will be used to clean the interior of the (b)(4) . However, there is no documentation or evidence to support that the (b)(4) chamber and its parts are cleaned and disinfected immediately prior to use. Your response also stated that you have not failed a sterility test in five years. However, a passing sterility test does not prove the sterility of each unit of each lot you produce and should not be solely relied upon as an indication of product sterility.

Your firm exposed (b)(4) vials that were used to produce drug products intended to be sterile to less than ISO 5 classified aseptic processing quality air. Specifically, trays of (b)(4) vials were improperly wrapped with foil and transferred from the ISO 8 area to the ISO 7 area without being disinfected. Therefore, sterile vials were exposed to less than ISO 5 quality air.

Your response stated that USP <797> does not specify the number of media filled units required to verify an employee’s aseptic technique and requested guidance on how many vials should be filled. You also stated that the kit vials are not designed to be (b)(4) , but that you will (b)(4) the media filled vials going forward. Our expectation is that the media fill is used to evaluate the aseptic process in addition to operator technique. Media fills should simulate the most…

Your media fills were not performed under the most challenging or stressful conditions and do not simulate your production process. Therefore, there is a lack of assurance that your firm can aseptically produce drug products within your facility.

Your firm used a non-sterile disinfectant within the ISO 5 aseptic processing area. 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 interstate commerce…

Your firm used household dish detergent to clean and sanitize glassware used in the production of sterile injectable drug products.

The investigator observed that an operator blocked first air by placing gloved hands directly over open sterile containers that were used to fill drug products intended to be sterile.