Description
Highlights actual 483 observations pertaining to manufacturing controls, laboratory controls and medical device manufacturers. This issue features observations pertaining to packaging and labeling. A sample:
“Specifically, the firm does not conduct investigation into deviations or Out of Specification test results todetermine the root cause or appropriate corrective or preventive action needed. Deviations are not thoroughlyinvestigated to determine whether the investigation should be extended to other batches. In addition, the OOSresults are not recorded in the batch records. Only repeat test results that are within specification are recordedin the batch record. Examples of OOS/deviations that were not investigated are…”
