Strides Pharma Science Limited — FDA 483 Findings

Laboratory controls shall include the establishment of scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards ofidentity, strength, quality, and purity.

Each component is not tested for conformity with all written specifications for purity, strength, and quality.

All records of production associated with a batch of drug product were not maintained at least one (1) year after the expiration date.

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 drug product.

Your firm failed to exercise controls over computerized manufacturing equipment to ensure that only authorized personnel can create and modify recipes, that obsolete or unauthorized recipes cannot be selected for commercial manufacturing, and that accurate data input is maintained across your facility's computerized systems.