Nora Apothecary and Alternative Therapies, Inc. – FDA 483, Mar 21, 2013

This FDA Form 483 documents significant deficiencies at a facility producing aseptically processed injectable drug products. The firm fails to conduct required sterility and endotoxin testing for each batch of distributed injectable drugs, with the last sterility test for Trimix on July 25, 2008, and no endotoxin testing ever performed. Potency testing is also inadequate; the last potency test for Trimix was July 25, 2008, and products like Bimix, Trimix, and PGE-1 are routinely released without assay testing.

Procedures to prevent microbiological contamination are not established or followed. There is no aseptic process validation (media fills). The ISO 5 hood, where aseptic procedures occur, is unclassified, has supplies stored within and above it, and lacks dynamic air testing or smoke studies. Aseptic operations observed deficiencies including exposed operator skin, non-deliberate movements, improper cleaning with ungloved hands, and no hand washing before gowning. Cleaning procedures are deficient, lacking sporicidal agents, specifying sterile IPA, or appropriate wipes, and do not describe gowning for cleaning. Non-sterile gowning materials are used. The firm fails to perform b 4 on b 4 and b 4 Inc. b 4. Incubation of environmental samples occurs in a dusty, untemperature-monitored area. A pre-filter, due for change b 4, has not been changed since December