1Equipment and facility
Suitable reader or photocopying equipment was not made readily available for drug product records maintained using reduction techniques.
Inspection Record
PharMEDium Services, LLC — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Training and personnel
Individuals responsible for supervising the manufacture and processing of a drug product lack the training to perform their assigned functions in such a manner as to assure the drug product has the safety, identity, strength, quality and purity that it prompts or is represented to possess.
3Deviation, CAPA, and investigation
Written records of investigations into unexplained discrepancies do not include the conclusions and follow-up.
4Documentation and records
Batch production and control records do not include the results of any investigation made into any unexplained discrepancy, whether or not the batch of diug product had ah eady been distributed.
5Quality unit oversight
The responsibilities and procedures applicable to the quality control unit are not fully followed.
6Deviation, CAPA, and investigation
Procedures are not established which are designed to assure that the responsible officials of the fnm, if they are not personally involved in or immediately aware of such actions, are notified in writing of investigations conducted.
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.
