Transdermal Therapeutics, Inc — FDA 483 Findings

Written procedures describing the handling of complaints do not include provisions for review by the quality control unit of a ny complaint involving tbe possible failure of a drug product to meet any of its specifications, a determination as to the need for an investigation ofany uncxplairied discrepancy, and explaining the reasons for the failure of the batch or any of its components to meet specifications .

There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess.

The calibration of recording devices is not done at suitable intervals in accordance with an establisbed written program.

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.

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

Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.

There is no written testing program designed to assess the stability characteristics of drug products.

Reserve drug product samples are not retained and stored under conditions consistent with product labeling.