bhaumik diversified llc – FDA 483, Nov 3, 2021

The FDA Form 483 details multiple observations from an inspection of a facility producing sterile and non-sterile drug products, including hazardous and potent drugs like hormones (Testosterone, Progesterone).

Key violations include inadequate segregation and cleaning of utensils to prevent cross-contamination of hazardous/potent drugs due to a lack of dedicated rooms, hoods, or equipment. Smoke studies were found inadequate, failing to demonstrate unidirectional airflow. Media fills did not simulate worst-case aseptic production conditions, with examples of high-volume sterile injectable batches (e.g., Kisspeptin-10, Glutathione, Nandrolone Decanoate) not being adequately represented.

Disinfection practices were insufficient; a sterile technician failed to meet the required 4-minute contact time for a sporicidal solution (b)(4) (Clostridium difficile spores require 4 minutes, but only 2 minutes were used), and no timer was available. Non-sterile (b)(4) was used in ISO-classified areas, with the sterile bottle compromised by removing the spray head and leaving it partially open. Non-sterile scissors and (b)(4) were used and stored exposed in the ISO7 buffer room during sterile drug production. Personnel failed to disinfect or change gloves after touching a garbage can before handling supplies and entering the ISO5 BSC.

The facility used non-pharmaceutical grade components (e.g., (b)(4), (b)(4), (b)(4)) in sterile