1Training and personnel
Clothing ofpersonnel engaged in the manufacturing and processing of drug products is not appropriate for the duties they perform.
Inspection Record
Loop Pharmacy & Home Medical — FDA 483 Findings
Inspectors Matthew B CasaleThe 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 are not established an d followed.
3Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
4Contamination control
Container closure systems do not provide adequate protection against foreseeable external factors in storage and use that can cause deterioration or contamination of the drug product.
5Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the to produce aseptic conditions.
6Aseptic processing and sterility assurance
Drug product containers and closures were not sterilized and processed to remove pyrogenic properties to assure that they are suitable for their intended use.
7Material and supplier control
There is a failure to thoroughly review the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
8Aseptic 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.
9Stability and storage
There is no written testing program designed to assess th e stability characteristics of dmg products .
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.
