NerPharMa S.r.l. — FDA 483 Findings

Laborato1y controls do not include the establishment of scientifically sound and appropriate sampling plans and test procedures designed to assure that components and dmg products confo1m to appropriate standards of identity, strength, quality and purity.

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.

Your fum failed to establish adequate written procedures for production and process controls designed to assure that the drng products have the identity, strength, purity, and quality that they are purpolied or represented to possess.

Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions.

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

Written records are not always made of investigations into unexplained discrepancies and the failure of a batch or any of its components to meet specifications.

Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.

Procedures designed to prevent microbiological contamination of diug products pmpo1ting to be sterile did not include adequate validation ofthe aseptic and sterilization process.