1Other quality system
Your firm’s Product Quality Reviews (PQRs) are deficient.
Inspection Record
Suven Life Sciences Ltd. — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Documentation and records
Manufacturing Batch Records are deficient.
3Material and supplier control
Procedures for sampling of raw materials were not followed.
4Labeling and packaging
Label access is not controlled.
5Training and personnel
Employees engaged in the manufacture, processing, packing, and holding of a drug product lack the training required to perform their assigned functions.
6Equipment and facility
Equipment and utensils are not cleaned and maintained to prevent contamination that would alter the safety, identity, strength, quality or purity of the Intermediates and APIs manufactured.
About this record
Extracted automatically from the document US FDA published on 2018-05-24. 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.
