1Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the equipment to produce aseptic conditions.
Inspection Record
Medi-Fare Drug Pharmaceutical Compounding LLC — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Process validation
Written procedures are not established, written and followed that describe the in-process controls, tests and examinations to be conducted on appropriate samples of in-process materials of each batch.
3Contamination control
The separate or defined areas and control systems necessary to prevent contamination or mix-ups are deficient.
4Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
5Deviation, CAPA, and investigation
Written records of investigations into the failure of a batch or any of its components to meet specifications do not always include the conclusions and follow-up.
6Training and personnel
Employees engaged in the manufacture and processing of a drug product lack the training required to perform their assigned functions.
7Stability and storage
An adequate number of batches of each drug product are not tested to determine an appropriate expiration date.
8Material and supplier control
Reports of analysis from component suppliers are accepted in lieu of testing each component for confonnity with all appropriate written specifications, without establishing the reliability of the supplier's analyses through appropriate validation of the supplier's test results at appropriate intervals.
9Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written and followed.
About this record
Extracted automatically from the document US FDA published on 2025-08-07. 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.
