Sato Pharmaceutical Co., Ltd. — FDA 483 Findings

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.

The quality control unit lacks the responsibility and authority to approve and reject all drug products.

The written stability program for drug products does not include specific test methods.

Laboratory controls do not 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 of identity, strength, quality and purity.

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 already distributed.

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

The accuracy, sensitivity, specificity and reproducibility of test methods have not been established and documented.

Protective apparel is not worn as necessary to protect drug products from contamination.

The written stability testing program is not followed.

Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic process.