FDA WARNING_LETTER - Standard Homeopathic Company, Inc. - October 28, 2010

The FDA issued a Warning Letter to Standard Homeopathic Company following a September 8, 2010, to October 28, 2010, inspection, identifying significant Current Good Manufacturing Practice (CGMP) violations for Finished Pharmaceuticals (21 C.F.R. Parts 210 and 211), rendering their drug products adulterated. The firm's November 10, 2010, response was deemed insufficient.

Key CGMP deviations include: 1. **Inadequate Production and Process Controls (21 C.F.R. § 211.100(a)):** Mixing times for products like Hyland's Teething Tablets and various 1X dilutions lacked adequate process validation. The use of surrogates in validation studies was not scientifically justified. 2. **Failure to Establish Time Limits for Production Phases (21 C.F.R. § 211.111):** No scientifically supported hold times were established for 1X dilutions (e.g., Chamomilla and Belladonna), leading to the use of aged dilutions in finished products. 3. **Failure to Conduct In-Process Testing (21 C.F.R. § 211.110(c)):** In-process testing for blend uniformity was not conducted for Belladonna 1X dilution; only sensory examinations were