FDA WARNING_LETTER - Hain Celestial Group - April 14, 2010

The FDA inspected Hain North America's dietary supplement facility in Boulder, Colorado, in March-April 2010, identifying numerous Current Good Manufacturing Practice (CGMP) violations (21 CFR Part 111) that rendered several herbal tea products adulterated. Key deficiencies included the failure to prepare and follow Master Manufacturing Records (MMR) (21 CFR 111.205(a)) and incomplete Batch Production Records (BPR) lacking critical information like equipment maintenance, theoretical yield, and QC review (21 CFR 111.255(b), 111.260).

The firm failed to establish required specifications for manufacturing process points, including component strength and finished product packaging/labeling (21 CFR 111.70). Laboratory operations were deficient, with unverified testing methodologies, inadequate documentation, insufficient facilities (e.g., non-operational microscope), and non-adherence to written procedures (21 CFR 111.320(a), 111.325(b)(2)(ii), 111.310(a), 111.303).

The quality control program was inadequate, lacking processes for approving/releasing labels/packaging, controlling label issuance, reviewing product complaints, periodically reviewing equipment calibration records, and managing returned dietary supplements (21 CFR 111.120(e), 111.410(b), 111.560(b), 111.117(c), 111.113(a)(5), 111.525(b)). Additional violations included not collecting representative samples of packaging/labels (21 CFR 111.80(a)), inadequate equipment calibration/review (21 CFR 111.30(c)), and insufficient personnel training (21 CFR 111.12(c)). The company's FDA-483 response lacked documentation of corrective actions. FDA requires a detailed response within 15 days with supporting documentation to prevent enforcement actions like product seizure or injunction.