Everlaan Organics, Inc. dba Maple Organics — FDA Warning Letter Findings

Your firm failed to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products (21 CFR 211.22(a)). The records and information you provided demonstrate that your quality unit (QU) did not effectively exercise its responsibilities to oversee the quality of your drug manufacturing operations. Specifically, your QU…

Your firm failed to conduct at least one test to verify the identity of each component of a drug product (21 CFR 211.84(d)(1)). Based on the records and information you provided about the manufacture of your OTC drug products, you did not demonstrate that you are adequately testing each shipment of each lot of incoming components. In response to our initial request, you state that you “identify all items via receiving practices” and provided a receiving procedure. However…

Your firm failed to prepare batch production and control records that include documentation of the accomplishment of each significant step in the manufacture, processing, packing, or holding of the batch, for each batch of drug product (21 CFR 211.188(b)). The batch records you provided in response to our request for records lacked adequate production details regarding significant manufacturing steps, including, but not limited to, identity of major equipment and lines…

Your firm failed to establish and follow an adequate written testing program designed to assess the stability characteristics of drug products (21 CFR 211.166(a)). The records and information you provided did not demonstrate that you have an adequate stability program for the OTC drug products you manufacture. You provided a stability test procedure that only discussed accelerated stability testing but did not include long-term stability testing. In lieu of stability data…