FDA WARNING_LETTER - Perfect Water and Essentials LLC, dba Aquagen International - August 06, 2015

The FDA issued a Warning Letter to Perfect Water and Essentials, LLC, dba Aquagen International, following an inspection from August 3-6, 2015. The inspection revealed serious violations of Current Good Manufacturing Practice (CGMP) regulations for dietary supplements (21 CFR Part 111), rendering products adulterated under 21 U.S.C. § 342(g)(1). Additionally, product labels were found to be misbranded under 21 U.S.C. § 343 and 21 CFR Part 101.

Key violations include: 1. Failure to conduct identity testing for dietary ingredients (e.g., sodium chloride, potassium hydroxide) prior to use (21 CFR 111.75(a)(1)(i)). The firm's response was insufficient as it lacked specific testing details. 2. Failure to prepare written Master Manufacturing Records (MMRs) for each unique formulation and batch size (21 CFR 111.205(a)). The provided MMR was incomplete and did not cover all products. 3. Batch Production Records (BPRs) lacked complete information, including dates/times of equipment maintenance/cleaning, documentation of manufacturing steps with initials, and documentation of packaging/labeling operations with unique identifiers and quantities (21 CFR 111.255(b), 11