FDA WARNING_LETTER - A Nelson & Co., Ltd. - November 17, 2011

This FDA Warning Letter, dated July 26, 2012, addresses A Nelson & Co., Ltd. following a November 14-17, 2011, inspection of their London pharmaceutical manufacturing facility. The inspection revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR Parts 210 and 211), rendering their drug products adulterated under 21 U.S.C. § 351(a)(2)(B). The firm's December 7, 2011, response was deemed insufficient.

Key CGMP violations include: 1. **Inadequate Production and Process Controls (21 CFR § 211.100(a)):** * **Glass Fragments:** Observed during Kali Phos 30 c Clikpak manufacture (Batch #36659), with insufficient measures to prevent contamination and lack of documentation for line clearance after breakage. The firm's response, citing a planned risk assessment, was unacceptable as quality cannot be added post-manufacture. A risk assessment for all U.S. market products within expiry and evidence of effective engineering upgrades are required. * **Inconsistent Dosing:** For Batch #36659, one in six bottles did not receive the active homeopathic drug solution due to bottle wobbling. The firm's response, attributing it to "