1Aseptic 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.
Inspection Record
Medlife Pharmacy and Compounding — FDA 483 Findings
Inspectors Yasamin AmeriThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Material and supplier control
Each lot of a component liable to objectionable microbiological contamination is deficiently subjected to microbiological tests before use.
3Contamination control
The separate or defined areas and control systems necessary to prevent contamination or mix-ups are deficient.
4Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and followed.
5Process validation
The in process control procedures were deficient in that they did not include an examination of the adequacy of mixing to assure uniformity and homogeneity.
6Laboratory and QC controls
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the prior to release.
7Stability and storage
There is no written testing program designed to assess the stability characteristics of dr ug products.
8Equipment and facility
The calibration of instruments is not done at suitable intervals.
9Equipment and facility
Records are not kept for the maintenance, cleaning, sanitizing and inspection of equipment.
10Equipment and facility
Equipment and utensils are not cleaned and sanitized at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
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.
