1Quality unit oversight
The responsibilities and procedures applicable to the quality control unit are not fully followed.
Inspection Record
L. Perrigo Co — FDA 483 Findings
Inspectors Patsy J Domingo · Regina T. Brown · Caroline H. LeThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Quality unit oversight
The quality control unit lacks responsibility for approving or rejecting drug products manufactured under contract by another company.
3Complaint and recall handling
An NDA-Field Alert Report was not submitted within three working days of receipt of information concerning a failure of one or more distributed batches of a drug to meet the specifications established for it in the application.
4Deviation, 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.
5Laboratory and QC controls
Laboratory records do not include the initials or signature of a second person showing that the original records have been reviewed for accuracy, completeness, and compliance with established standards.
6Material and supplier control
For components removed from the original containers, the new container fails to be identified with component name or item code, receiving or control number, weight or measure, and batch for which component was dispensed including product name, strength and lot number.
7Stability and storage
Results of stability testing are not used in determining expiration dates.
8Deviation, CAPA, and investigation
There is a failure to thoroughly review any unexplained discrepancy and 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.
9Quality unit oversight
Drug product production and control records, are not reviewed by the quality control unit to determine compliance with all established, approved written procedures before a batch is released or distributed.
10Quality unit oversight
The quality control unit lacks the responsibility and authority to reject all drug 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.
