FDA WARNING_LETTER - Desert Stream, Inc. - September 17, 2014

On September 15-17, 2014, the FDA inspected Desert Stream, Inc.'s dietary supplement manufacturing facility in Nephi, Utah, revealing serious violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 111). These violations render their dietary supplement products adulterated under 21 U.S.C. § 342(g)(1).

Additionally, product labeling review identified significant violations. Products like "(b)(4) for Arthritis Discomforts" are deemed unapproved new drugs under 21 U.S.C. § 321(g)(1)(B) due to therapeutic claims, making them misbranded under 21 U.S.C. § 352(f)(1) for lacking adequate directions for layperson use.

CGMP violations include: 1. Failure to establish and follow written quality control procedures (21 CFR 111.103, 111.65). 2. Batch production records (BPRs) not accurately following master manufacturing records (MMRs), with discrepancies in component usage and quantities (21 CFR 111.255(c)). 3. BPRs lacking complete information, such as equipment identity, cleaning dates, component unique identifiers, yield statements, test results, verification initials, labels, and quality personnel approval (21 CFR 11