FDA WARNING_LETTER - kreativ health inc - July 31, 2012

The FDA conducted an inspection of Kreativ Health, Inc. dba Natural Food Supplements from July 26-31, 2012, revealing significant Current Good Manufacturing Practice (CGMP) violations under 21 CFR Part 111, rendering their dietary supplements adulterated. Key CGMP deficiencies included failure to conduct identity testing for dietary ingredients, establish component and product specifications, qualify suppliers, implement laboratory control processes for sampling, approve and release components/packaging/labels from quarantine, document quality control approval in batch records, maintain written equipment procedures, ensure proper packaging/labeling via master manufacturing records, establish complete batch production records, keep training documentation, and establish written procedures for product complaints and returned dietary supplements. Beyond CGMP, several products were found to be misbranded under sections 403(q)(5)(F), 403(i)(1), 403(s)(2)(B), and 403(y) of the Act and 21 CFR Part 101. Misbranding issues included lacking "Supplement Facts" panels, failing to identify products as "dietary supplements," and omitting domestic adverse event reporting contact information. Furthermore, the "Super MSM" product was deemed an unapproved new drug under sections 201(g)(1)(B) and 201(p) of the Act due to disease treatment claims ("relieves joint pain") without FDA approval. The firm's responses to the FDA-483 were largely inadequate. FDA requires prompt corrective actions, a written response within 15 working days detailing steps taken, and a timetable for remaining corrections, warning of potential regulatory actions like product seizure or injunctions, and reinspection fees.