Zhejiang Huahai Pharmaceutical Co., Ltd. — FDA 483 Findings

Laboratory records do not include complete data derived from all tests, examinations, and assay necessary to assure compliance with established specifications and standards.

Backup data is not assured as exact, complete and secure from alteration, erasure or loss through keeping hard copy or alternate systems.

Equipment and utensils are not maintained at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.

Laboratory Controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that components, in-process materials and drug products conform to appropriate standards of identity, strength, quality and purity.

You do not have written procedures and process control procedures to ensure and document that all key process parameters are controlled and any deviations from the procedures are justified.

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

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

Written records of investigation of a drug complaint do not include the follow-up.

Procedures designed to prevent microbiological contamination ofdrug products purporting to be sterile are not established, written, followed, or including adequate validation of the sterilization process.