JD & SN Inc., dba Moses Lake Professional Pharmacy — FDA 483 Findings

There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already dist ri buted.

Test procedures relative to appropriate laboratory testing for sterility and pyrogens are not written and followed.

Routine calibration of equipment is not performed according to a written program designed to assure proper performance.S pecifically, the firm does not have any written procedure requiring the calibration of weights and thermometers.

Batch production and control records do not include complete infonnation relating to the production and control of each batch.

Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established.

Procedures designed to assure that correct labeling are used for drug products are not written.

Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.

Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the to produce aseptic conditions.

Drug products do not bear an expiration date determined by appropriate stability data to assure they meet applicable standards of identity, strength, quality and purity at the time of use.

The master production and control records are deficient in that they do not include complete instructions.

Protective apparel is not worn as necessary to protect drug products from contamination.

Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriare design to facilitate op eration s for its intended use.