1Stability and storage
There is no written testing program designed to assess the stability characteristics of drug products.
Inspection Record
Pharmacy Resources Incorporated — FDA 483 Findings
Inspectors Zachery L MillerThe 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
Protective apparel is not worn as necessary to protect diug products from contamination.
3Equipment and facility
Routine calibration of equipment is not performed according to a written program designed to assure proper performance.
4Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room equipment to produce aseptic conditions.
5Laboratory and QC controls
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.
6Aseptic processing and sterility assurance
Aseptic processing areas ar e deficient regarding the system for monitoring environmental conditions .
7Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products pur porting to be sterile do not include adequate validation of the sterilization process.
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.
