1Training and personnel
Employees are not given training in the particular operations they perform as part of their function and current good manufacturing practices.
Inspection Record
Dr. Reddy's Laboratories Limited — FDA 483 Findings
Inspectors Saleem A AkhtarThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Laboratory and QC controls
Determinations of conformance to appropriate written specifications for acceptance are deficient for drug products.
3Laboratory and QC controls
Laboratory records are deficient in that they do not include a complete record of all data obtained during testing.
About this record
Extracted automatically from the document US FDA published on 2023-12-28. 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.
