FDA WARNING_LETTER - Homeolab USA Inc. - January 13, 2017

The FDA issued a Warning Letter to Homeolab USA Inc. (part of Homeocan Inc.) following a January 9-13, 2017, inspection of their Montreal, Quebec drug manufacturing facility. The letter identifies significant violations of current Good Manufacturing Practice (CGMP) regulations (21 CFR, parts 210 and 211), rendering their drugs adulterated under section 501(a)(2)(B) of the FD&C Act.

Key violations include: 1. **Failure to validate manufacturing processes (21 CFR 211.110(a)):** The firm released multiple lots of homeopathic in-process powder blends, including those containing potentially toxic ingredients like belladonna for Infants' Teething Tablets, without validating the manufacturing process. FDA analyses of in-process and finished drugs showed non-homogeneous composition. The firm's subsequent validation attempt was deemed inadequate, lacking scientific justification for surrogate use, well-defined acceptance criteria, and an ongoing monitoring program. 2. **Failure to test components (21 CFR 211.84(d)(1) and (2)):** The firm did not perform adequate identity testing for components (e.g., belladonna) or validate test results for purity, strength, and quality. Relying on supplier Certificates of Analysis without adequate validation was cited.

The FDA also noted that a consultant impeded the inspection by preventing