1Stability and storage
An adequate number of batches of each drug product are not tested to determine an appropriate expiration date.
Inspection Record
Pharmacy Creations — FDA 483 Findings
Inspectors Douglas C. Kovacs · Michael R. KlapalThe 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
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include adequate validation ofthe sterilization process.
3Aseptic processing and sterility assurance
Each batch of drug product purporting to be sterile is not laboratory tested to determine conformance to such requirements.
4Aseptic processing and sterility assurance
Drug product containers were not sterilized and processed to remove pyrogenic properties to assure that they are suitable for th eir intended use.
5Aseptic 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.
