Lupin Limited — FDA 483 Findings

(Repeat) There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been ah-eady distributed.

The responsibilities and procedures applicable to the quality control unit are not [in writing] [fully followed].

(Repeat) Written records of investigation of a dtug complaint do not include the findings of the investigation and the follow-up.

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

(Repeat) Employees engaged in the manufacture, processing, packing and holding of a drng product lack the training required to perfo1m their assigned functions.

(Repeat) 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.

Substances required for equipment operations such as lubricants and coolants come in contact with diu g product containers, closures, dmg product so as to alter the safety, identity, strength, quality, or purity of the dmg product beyond the official or other established requirements.

Procedures designed to prevent microbiological contamination of dm g products purporting to be sterile are not established, written, or followed.

Laborato1y controls do not include the establishment ofscientifically sound and appropriate specifications, test procedures designed to assure that components, drug products confo1m to appropriate standards of identity, strength, quality and purity.

Equipment for adequate control over air pressure, humidity, temperature is not provided when appropriate for the manufacture, processing, packing or holding ofa diug product.