FDA WARNING_LETTER - newton laboratories inc - March 30, 2018

The FDA issued a Warning Letter to Newton Laboratories, Inc. following a March 26-30, 2018 inspection, citing significant violations of CGMP regulations for finished pharmaceuticals (21 CFR, parts 210 and 211). The firm's drug products are deemed adulterated under 21 U.S.C. 351(a)(2)(B).

Key violations include: 1. **Failure to thoroughly investigate discrepancies (21 CFR 211.192):** The firm released homeopathic drug products despite failing microbial test results for water and finished products, without adequate investigation into root causes, patient risk, or corrective actions. 2. **Failure to establish written production and process controls (21 CFR 211.100(a)):** Manufacturing processes were not validated, a repeat observation from 2012 and 2017, risking inconsistent product quality and potentially toxic ingredients like Nux vomica. 3. **Inadequate equipment cleaning and maintenance (21 CFR 211.67(a)):** Non-dedicated equipment showed microbial and TOC contamination after cleaning, indicating cross-contamination risk. 4. **Failure to conduct annual product reviews (21 CFR 211.180(e)):** Annual reviews for homeopathic drugs were not performed, a repeat observation from 2006 and 20