1Other quality system
Detenninations of confonnance to appropriate written specifications for acceptance are deficient for diug products.
Inspection Record
Dr. Reddy's Laboratories Ltd. — FDA 483 Findings
Inspectors Saleem A Akhtar · Pratik S UpadhyayThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Equipment and facility
Buildings used in the manufacturing and processing ofa diug product are not maintained in a good state of repair.
3Complaint and recall handling
Procedures describing the handling of written and oral complaints related to diug products are deficiently written or followed.
4Laboratory and QC controls
The accuracy, sensitivity, specificity and reproducibility oftest methods have not been established.
5Other quality system
The use of instruments, apparatus and recording devices not meeting established specifications was observed.
6Computer system validation
Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.
7Quality unit oversight
The responsibilities and procedures applicable to the quality control unit are not fully followed.
8Equipment and facility
Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drng product.
9Process validation
Your fnm failed to establish adequate written procedures for production and process controls designed to assure that the diug products have the identity, strength, purity, and quality that they are purpo1ted or represented to possess.
About this record
Extracted automatically from the document US FDA published on 2023-11-29. 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.
