C&T Dream Co., Ltd. — FDA 483 Findings

The containers of components, or drug product containers or closures which are sampled are not opened in a manner to prevent contamination of their contents, contamination of other components, contamination of other drug product containers and contamination of other closures.

Buildings used in the manufacturing, processing, packing and holding of a drug product are not maintained in a good state of repair.

Laboratory records are deficient in that they do not include a complete record of all data obtained during testing.

Where data from accelerated studies was used to project a tentative expiration date beyond a date supported by actual shelf life studies, there were no stability studies and drug product testing at appropriate intervals conducted until the tentative expiration date was verified or the appropriate expiration date determined.

Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity with all appropriate written specifications, without performing at least one specific identity test on each component and establishing the reliability of the supplier's analyses through appropriate validation of the supplier's test results at appropriate intervals.

Control procedures are not established which monitor the output and validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in- process material and the drug product.

Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use.

Equipment for adequate control over air pressure, micro-organisms, dust, humidity and temperature is not provided when appropriate for the manufacture, processing, packing or holding of a drug product.