Jubilant Generics Limited — FDA 483 Findings

Investigations of any unexplained discrepancy, a failure of a batch or any of its components to meet any of its specifications did not extend to other drug products that may have been associated with the specific failure or discrepancy.

Equipment and utensils are not cleaned, maintained, and sanitized at appropriate intervals to prevent malfunctions and contamination that would alter the safety, identity, strength, quality or purity of the drug product.

Laboratory controls do not include the establishment of scientifically sound and appropriate, sampling plans designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality and purity.

Control procedures are not established which validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.

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.

Backup data is not assured as exact, complete, and secure from alteration, erasure or loss through keeping hard copy or alternate systems.

The quality control unit lacks authority to review production records to assure that no errors have occurred and fully investigate errors that have occurred.