1Equipment and facility
Routine calibration and checking of equipment is not performed according to a written program designed to assure proper performance.
Inspection Record
Home Intensive Care Pharmacy, LLC — 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
2Stability and storage
There is no written testing program designed to assess the stability characteristics ofdrug products.
3Training and personnel
Clothing of personnel engaged in the processing of drug products is not appropriate for the duties they perform.
4Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
5Aseptic processing and sterility assurance
Each batch of drug product purporting to be sterile and pyrogen-free is not laboratory tested to determine conformance to such requirements.
6Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include adequate validation of the sterilization process.
7Aseptic processing and sterility assurance
Aseptic process ing areas are deficient regarding the system for cleaning and dis infecting the room and equipment to produce aseptic conditions.
8Deviation, CAPA, and investigation
Written records of investigations into the failure ofa batch or any of its components to meet specifications do not always include the conclusions and follow-up.
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.
