The Glutathione Corporation – FDA Warning Letter, Oct 1, 2012

The FDA inspected The Glutathione Corporation's dietary supplement facility from September 19 to October 1, 2012, identifying serious violations of 21 CFR Part 111 (CGMP for dietary supplements), rendering products adulterated.

Key violations include: * **Lack of Component Specifications and Identity Testing:** No established specifications for L-Glutathione Reduced or other dietary ingredients, and no documented identity testing (21 CFR 111.70(b), 111.75(a)(1)(i)). * **No Finished Product Testing:** Failure to verify finished product specifications for identity, purity, strength, composition, and contamination for numerous products (21 CFR 111.75(c)). * **Absence of Master Manufacturing Records:** No written master manufacturing records for any unique dietary supplement formulations (21 CFR 111.205(a)). * **Incomplete Batch Production Records:** Batch records for Ultrathione 500 Glutathione and Daily Essentials lacked crucial information like documentation of manufacture at time of performance, dates/initials for steps, ingredient weighing/verification, equipment cleaning/sanitizing records, and actual/theoretical yield (21 CFR 111.255(b), 111.260). * **No Quality Control Procedures:** Failure to establish written procedures for quality control