1Other quality system
Failure to implement, in a timely manner, the new HPLC methods for assay and 3 Chromatographic impurities of Theophylline API and finished product.
Inspection Record
Schering-Plough Products, LLC — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Other quality system
During the review of 2 Wariance Report No.
3Deviation, CAPA, and investigation
Your laboratory failure investigations are inadequate in that you re-test without any scientific © justification until passing results are obtained and/or fail to take correctiveactions to prevent recurrence of the possible assigned cause: | a.
4Other quality system
The Transaction History Report System does not provide accurate data.
5Other quality system
During the performance of the content uniformity for UNI-DUR 600 mg ER tablets lo SPREE.
6Stability and storage
You fail to have stability studies to justify extensive holding times ofyour oe | en products stored in bulk containers until packaged for release to distribution.
7Equipment and facility
Your equipment cleaning SOP for the Rigavirin production line is inadequate in that it fails to require that a mayor cleaning be executed between lots of Rivavirin obtained from an approved drug substance supplier and a non-approved supplier.
8Other quality system
There fs no documentation to account for the disposition of 140 kilograms (100 Se kg.
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.
