FDA WARNING_LETTER - Homeocare Laboratories, Inc. - January 11, 2017

The FDA inspected HomeoCare Laboratories, Inc. from January 4-11, 2017, identifying significant CGMP violations for finished pharmaceuticals, rendering their drug products adulterated. Additionally, HBP Relief, Cholestop, and IBS Relief were deemed misbranded.

Key violations include: 1. **Failure to establish adequate written production and process control procedures (21 CFR 211.100(a))**: The firm manufactures homeopathic drugs with potentially toxic ingredients (e.g., Nux vomica) but failed to validate manufacturing processes, posing patient risks. The response regarding SOPs was inadequate as it didn't address process validation or risk assessment for distributed products. 2. **Failure to establish and follow adequate in-process controls (21 CFR 211.110(a))**: In-process testing was limited and relied on subjective visual assessments, failing to ensure batch uniformity and homogeneity, especially for toxic ingredients. The firm's updated procedures were insufficient. 3. **Failure to test components for identity and establish supplier reliability (21 CFR 211.84(d)(1) & (2))**: The firm did not test each component for identity or verify supplier analyses. For example, Nux vomica was not assayed for strychnine, and some components lacked Certificates of Analysis. The firm's response was inadequate, as all components require identity testing,