Wood’s Pharmacy, Inc., dba The Medicine Shoppe — FDA 483 Findings

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

Laboratory controls do not include the establishment ofscientifically sound and appropriate specifications designed to assure that components conform to appropriate standards of identity, strength, quality and purity.

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

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

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.

Laboratory records do not include complete records of the periodic calibration of laboratory instruments.

Control procedures are not established which 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.