1Contamination control
Protective apparel is not worn as necessary to protect drug products from contamination.
Inspection Record
One Way Drug, LLC dba Partell Specialty Pharmacy — FDA 483 Findings
Inspectors Ashar P. ParikhThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Laboratory and QC controls
Each batch of drug product required to be free of objectionable microorganisms is not tested through appropriate laboratory testing.
3Stability and storage
There is no written testing program designed to assess the stability characteristics ofdrug products.
4Aseptic processing and sterility assurance
Drug product containers were not sterilized and processed to remove pyrogenic properties to assure that they are suitable for their intended use.
5Equipment and facility
Written procedures are lacking for the use of cleaning and sanitizing agents designed to prevent the contaminat ion of equipment, components, drug product containers, and drug products.
6Complaint and recall handling
Procedures describing the handling of written and oral complaints related to drug products are not written or followed.
7Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include ade quate 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.
