Imprimis NJOF, -LLC — FDA 483 Findings

(REPEAT OBSERVATION) Laboratory controls do not include the establishment of scientifically sound and appropriate sampling plans designed to assure that drug products conform to appropriate standards of identity, strength, qualify and purity.

Your outsourcing facility compounds drug products using-bulk drug·substances that cannot be used in compounding under section 503B because they (a) &re not used to compounded drug products that appear on the drug shortage list in effect under section 506E of-the Act end (b) «io not appear on· a list developed by FDA of bulk drug substances for which there is a clinical need.

There is a lack of written procedures assigning· responsibility, providing :cleaning schedule§ describing in sufficient detail the methods, equipment and materials to be used for sanitation.

(REPEAT OBSERVATION) The quality control unit lacks the responsibility and authority to reject all in process materials and drug products.

(REPEAT OBSERVATION) 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.

(REPEAT OBSERVATION) There is a failure to thoroughly review any unexplained discrepancy, the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.

Your outsourcing facility did not submit a report to FDA identifying the drugs compounded drugs during the previous· six-month period.