FDA 483 - Gilead Sciences Inc - February 12, 2010

This FDA Form 483 documents observations from an inspection related to the aseptic processing of drug products. The facility exhibits deficiencies in several areas.

Regarding facility and operations, separate or defined areas to prevent contamination or mix-ups are inadequate for aseptic processing. The system for monitoring environmental conditions in aseptic processing areas is deficient, as are systems for maintaining equipment used to control aseptic conditions. Buildings used for holding drug products are not maintained in a good state of repair.

Quality system and manufacturing issues include equipment and utensils not being cleaned and sanitized at appropriate intervals to prevent contamination. Procedures designed to prevent microbiological contamination of sterile drug products are not followed, and these procedures lack adequate validation of the sterilization process.

Laboratory controls are deficient, specifically in the establishment of scientifically sound and appropriate sampling plans and test procedures to assure drug product conformity to standards of identity, strength, quality, and purity. Acceptance criteria for sampling and testing by the quality control unit are inadequate to assure batches meet specifications and statistical quality control criteria for release. Finally, written procedures for annual evaluations of batch records (approved or rejected) are not followed.