1Equipment and facility
The equipment used in the manufacture, processing, and packing offyee and) MMi not of adequate construction and design for its intended use.
Inspection Record
Sanofi Winthrop Industrie — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Equipment and facility
Routine calibration and inspection of electronic equipment is not performed according to a written program designed to assure proper performance.
3Complaint and recall handling
The written complaint record did not include the reason an investigation was found not to be necessary when an investigation into unexplained discrepancies was not conducted.
4Deviation, CAPA, and investigation
The following investigations were found inadequate: (0)(4) A.
5Validation and qualification
The following qualification/requalification studies were found deficient: A.
6Other quality system
The controlled areas within the manufacturing department are not maintained in a state ofcontrol.
7Material and supplier control
Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity with all appropriate written specifications, establishing the reliability of the supplier's analyses through appropriate validation of the supplier's test results at appropriate intervals.
8Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination af drug products ournorting to be sterile are not established.
9Equipment and facility
Equipment and utensils are not sanitized at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
10Regulatory reporting and change control
The firm does not have a thorough understanding ofthe requirements for submission of OMe ield Alerts.
11Other quality system
The firm does not have scientific rationale or justification for the placementoFtheir nopviable particle monitors.
About this record
Extracted automatically from the document US FDA published on 2016-11-29. 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.
