1Aseptic processing and sterility assurance
The final containers/closures used for drug product intended to be sterile have not been sterilized or de pyrogenated.
Inspection Record
Civic Center Pharmacy Inc. — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Training and personnel
Personnel were observed using a non-sterile tool or manually contact the inner surface of the container or closure.
3Documentation and records
The batch records do not record the distinctive identification number, code and name of equipment to identifY major equipment to show the specific equipment used in the manufacture of a batch of a drug product.
4Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air filters under positive pressure.
5Aseptic processing and sterility assurance
There is inadequate HEPA filter coverage or airflow over the area to which sterile product is exposed.
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.
