FDA WARNING_LETTER - NDAL Mfg Inc. - September 20, 2021

The FDA inspected NDAL Mfg Inc. (FEI 3011219618) in Monterey, CA, from September 8-20, 2021, identifying significant Current Good Manufacturing Practice (CGMP) violations, rendering their drug products adulterated under 21 U.S.C. 351(a)(2)(B). Additionally, MANUKA HONEY ALLERCLEANSE Nasal Spray, MANUKA HONEY SINUS CLEANSER, and MANUKA HONEY EXTRA STRENGTH NASAL SPRAY ALLERCLEANSE are deemed unapproved new drugs, violating 21 U.S.C. 355(a).

Key violations include: 1. **Quality Control Unit Failure (21 CFR 211.22):** The firm lacked an adequate quality unit and procedures for component approval, OOS investigations, and complaint evaluation. They could not provide specifications used by CMOs for product release. The firm's response, detailing intent to establish a QU and hire a Quality Manager, was inadequate due to lack of a detailed risk assessment for released products and insufficient detail on CMO oversight. 2. **Inadequate Investigations (21 CFR 211.192):** The firm failed to thoroughly investigate microbial contamination in ManukaGuard Allercleanse nasal spray lot 2010045, lacking scientific justification for root