1Training and personnel
Clothing of personnel engaged in the processing of drug products is not appropriate for hte duties they perform.
Inspection Record
Franck's Lab Inc dba Trinity Care Solutions — FDA 483 Findings
Inspectors Joanne E. King · Lacresha D. Chatman · Lesley K. SatterwhiteThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Contamination control
The separate or defined areas and control systems necessary to prevent contamination or mix-ups are deficient.
3Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions.
4Equipment and facility
Buildings used in the manufacture, processing, packing or holding of drug products are not maintained in a clean and sanitary condition and free of infestation by rodents, birds insects, and other vermin.
5Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established.
6Aseptic processing and sterility assurance
Aseptic processing areas are deficient in that walls are not smooth and/or bard surfaces that are easily cleanable.
About this record
Extracted automatically from the document US FDA published on 2024-01-17. 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.
