FDA WARNING_LETTER - MSM Nutraceuticals, LLC dba MSM Health Solutions - May 08, 2019

The FDA inspected MSM Nutraceuticals, LLC from April 30 to May 8, 2019, revealing significant CGMP violations (21 CFR parts 210 and 211) and unapproved new drug charges. The firm's "MSM PAIN GEL" and "MSM NASAL SPRAY" products were deemed adulterated and unapproved new drugs under the FD&C Act. CGMP deficiencies included inadequate laboratory testing for identity, strength, and microbial limits of finished products, with "MSM NASAL SPRAY" found subpotent. The firm lacked established procedures for production and process control, including process validation and proper control of its purified water system. Furthermore, MSM Nutraceuticals failed to support drug product expiration dates with stability testing and did not conduct identity testing for incoming components or validate supplier certificates of analysis, specifically for glycerin. Both "MSM PAIN GEL" and "MSM NASAL SPRAY" were cited as unapproved new drugs (FD&C Act section 201(p)) lacking general recognition of safety and effectiveness and approved applications. The firm ceased drug production and recalled MSM eye drops. FDA recommended a CGMP consultant. A written response within 15 working days is required, detailing comprehensive corrective actions, including independent assessments of quality systems, and clarifying future manufacturing plans. Non-compliance may lead to legal action.