1Laboratory and QC controls
The accuracy , sensitivity, and reproducibility oftest methods have not been established.
Inspection Record
Meridian Medical Technologies, Inc. — FDA 483 Findings
Inspectors Anthony R. Bucks · Kathleen B. Swat · Michele Perry WilliamsThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Deviation, CAPA, and investigation
Investigations of a failure of a batch or any of its components to meet any of its specifications did not extend to other drug products that may have been associated with the specific failure or discrepancy.
3Quality unit oversight
The quality control unit lacks authority to review production records to assure that no errors have occurred and fully investigate errors that have occurred.
4Other quality system
Drug products failing to meet established standards are not rejected.
5Training and personnel
Employees engaged in the manufacture, processing, packing, and holding ofa drug product lack the training required to perform their assigned functions.
6Stability and storage
The written stability program for drug products does not include test intervals based on statistical criteria for each attribute examined to assure valid estimates ofstability.
7Laboratory and QC controls
Testing and release of drug product for distribution don not include appropriate laboratory determination of satisfactor y conformance to the final specifications prior to release.
8Material and supplier control
Representative samples are not taken of each shipment ofeach lot ofcomponents, drug product containers, and closures for testing or examination.
9Complaint and recall handling
An NDA-Field Alert Report was not submitted within three working days of receipt ofinfonnation concerning a failure of one or more distributed batches ofa drug to meet the specifications established for it in the application.
10Labeling and packaging
Reserve drug product samples are not retained and stored under conditions consistent with product labeling.
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.
