1Cleaning validation
In your April 6, 2020 response to Observation 14 of the Form FDA 483, you stated that you have segregated all hazardous drug products and are working with a third-party vendor to develop procedures and to obtain a deactivation agent. However, you have not provided adequate information and documentation for us to fully evaluate your response, such as revised cleaning procedures. Please be aware that section 501(a)(2)(A) of the FDCA concerning insanitary conditions applies…
2Equipment and facility
In your April 6, 2020 response to Observation 2 of the Form FDA 483, you stated that the “Pharmacy conducted a deep clean of all areas where vermin were observed …[and] brought in pest control services on 3/10/20, the day after the initial inspection.” Further, you stated that the “pest control company will continue to service the pharmacy (b)(4) for an indefinite period...” You provided two photos. However, you did not provide adequate information and documentation such as the cleaning schedule or the pest remediation actions for us to be able to fully evaluate your response.
3Contamination control
Non-microbial contamination was present in your production area. Specifically, your firm’s (b)(4) hoods contained stained balances and one of the hoods contained stains within close proximity to the (b)(4) air filters.
4Other quality system
Your production area contained unsealed, loose ceiling tiles, including one cracked, and one stained ceiling tile.
5Contamination control
In your April 6, 2020 response to Observation 13 of the Form FDA 483, you state that you have replaced unsealed, cracked and stained ceiling tiles and will maintain all ceiling tiles in clean condition. However, you have not provided adequate information and documentation for us to fully evaluate your response. Additionally, one of the pictures provided in response to Observation 6 of the Form FDA 483 appears to show visible brown stain indicative of water damage on one of the ceiling tiles, still. We remain concerned about the potential impact of the visibly brown stained tiles and any water damage that could potentially cause mold growth and contamination in production areas.
6Equipment and facility
Your firm failed to maintain the buildings used in the manufacture, processing, packing, or holding of a drug product in a clean and sanitary condition and to keep them free of infestation by rodents, birds, insects, and other vermin (21 CFR 211.56(a)).
7Equipment and facility
Your firm handled hazardous drug products without providing adequate containment, segregation, or cleaning of work surfaces and utensils to prevent cross-contamination. Furthermore, the manufacture of the ineligible drug products is subject to FDA’s CGMP regulations, Title 21, Code of Federal Regulations (CFR), parts 210 and 211. The FDA investigators observed significant CGMP violations at your facility, causing the ineligible drug products to be adulterated within the meaning of section 501(a)(2)(B) of the FDCA. The violations included, for example…
8Equipment and facility
Your firm failed to clean, maintain, and, as appropriate for the nature of the drug, sanitize and/or sterilize equipment and utensils at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements (21 CFR 211.67(a)). 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…
9Equipment and facility
Vermin were present in your production area. Specifically, dead ants were observed on the floor of the unclassified general production area, and dead cockroaches were observed within a drawer adjacent to the (b)(4) hood where drug products were produced.
10Cleaning validation
In your April 6, 2020 response to Observation 5 of the Form FDA 483, you state that you have removed the clutter from the (b)(4) hoods, will keep the area within and around the (b)(4) hoods clutter free, and will clean the area within and surrounding the (b)(4) hoods after every use. You also provided two photos. However, you did not provide adequate information and documentation, such as completed cleaning logs and revised cleaning procedures, for us to fully evaluate your proposed corrections.
