1Training and personnel
Clothing of personnel engaged in the manufacturing, processing, and packing of drug products is not appropriate for the duties they perform.
Inspection Record
Baptist Health Medical Towers Pharmacy and Infusion Services — FDA 483 Findings
Inspectors Latorie S JonesThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air filters under positive pressure.
3Equipment and facility
Routine calibration of automatic and electronic equipment is not performed according to a written program designed to assure proper performance.
4Deviation, CAPA, and investigation
Investigations of an unexplained discrepancy and a failure of a batch or any of its components to meet any of its specifications did not extend to other drug products that may have been associated with the specific failure or discrepancy.
5Aseptic processing and sterility assurance
Test procedures relative to appropriate laboratory testing for sterility are not followed.
6Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions.
7Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination ofdrug produels purporting to be sterile are not followed.
8Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
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.
