1Equipment and facility
HEPA filters were not sealed around each perimeter to the support frame.
Inspection Record
New Vitalis, LLC dba New Vitalis Pharmacy — FDA Warning Letter Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Equipment and facility
Vermin were observed in an area immediately adjacent to the firm’s production area.
3Training and personnel
Personnel donned gowning apparel improperly in a way that may have caused the gowning apparel to become contaminated.
4Contamination control
Your firm handled hazardous drug products without providing adequate cleaning of utensils to prevent cross-contamination. 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…
5Aseptic processing and sterility assurance
An operator blocked first air by placing gloved hands directly over open sterile containers.
6Environmental monitoring
Production areas were difficult to clean or contain porous, particle generating, or visibly dirty surfaces. Specifically, debris on the floor, peeling (b)(4) tape with an apparent build-up of black residue on the floor in the ISO 7 cleanroom, and black residue build-up around (b)(4) HEPA filters were observed.
7Material and supplier control
Personnel failed to disinfect gloves and components to prevent contamination.
About this record
Extracted automatically from the document US FDA published on 2022-05-31. The source is available at the link above.
This is a record of that moment. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out. Do not read it as the current state; check the regulator's official announcements for the latest status.
Translation and classification are automated and may differ in nuance from the source.
