Imprimis NJOF LLC — FDA 483 Findings

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

The quality control unit lacks the responsibility and authority to approve and reject all components, in process materials and drug products.

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

Your firm failed to establish written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess.