Chen Shwezin dba Park Compounding Pharmacy — FDA 483 Findings

Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the identity and strength of each active ingredient prior to release.

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.

Each lot of a component that is liable to microbiological contamination that is objectionable in view of its intended use is not subjected to microbiologieal tests before use.

Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not established, written, and followed.

Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, sampling plans, and test procedures designed to assure drug products conform to appropriate standards of identity, strength, quality and purity.