Apotheca, Inc — FDA 483 Findings

08/19/2008 - 08/28/2008* FE/NUMBER 1931484 TYPE ESTABUSHMENT INSPECTED Homeopathic Drug Manufacturing Batch production and control records do not include the results ofany investigation made into any unexplained discrepancy, whether or not the batch of drug product had already been distributed.

Control procedures are not established which validate the perfonnance ofthose manufacturing processes that may be responsible for causing variability in the characteristics ofin-process material and the drug product.

08/19/2008 - 08/28/2008* FE NUMBER 1931484 STREET AOORESS 313 Lowrey Dr 1i'PE ESTAllUSHMENT INSPECTED Homeopathic Drug Manufacturing Batch production and control records do not include the identity ofindividual major equipment used for each batch ofdrug product produced.

Each lot of components, drug product containers, and closures is not withheld from use until the lot has been sampled, tested, examined, and released by the quality control unit.

08/19/2008 - 08/28/2008* FElNUMBER 1931484 TYPE ESTASUSHMENT INSPECTED Homeopathic Drug Manufacturing Investigations ofan unexplained discrepancy did not extend to other batches ofthe same drug product and other drug products that may have been associated with the specific failure or discrepancy.

08/19/2008 - 08/28/2008* FE/NUMBER 1931484 TYPE ESTABLISHMENT INSPECTED Homeopathic Drug Manufacturing Batch production and control records do not include the results of any investigation made into any unexplained discrepancy, whether or not the batch of drug product had already been distributed.