Loading…
Novel Laboratories, Inc. d.b.a. Lupin, a pharmaceutical manufacturer in Somerset, New Jersey, failed to establish and follow adequate written procedures for cleaning and maintenance of equipment used to manufacture finished drug products, in violation of current good manufacturing practice (CGMP) regulations. During an FDA inspection from September to November 2020, investigators documented drug residue from previously manufactured products inside tablet presses and associated equipment that had been released as clean by the company's quality unit, creating risk of cross-contamination across multiple potent and non-potent drug products. The company's cleaning procedures for non-dedicated equipment were found to be inadequate, and preventative maintenance procedures for equipment installed in 2008 lacked proper cleaning instructions and regular inspection protocols for critical areas such as air ducts. These violations rendered the firm's drug products adulterated under federal law.