FDA WARNING_LETTER - Prime Herbs Corporation - August 14, 2012

On December 10, 2012, the FDA issued a Warning Letter to Prime Herbs Corporation following an inspection from August 7-14, 2012. The inspection found that the firm's Precision TDP Floor Lamp (Infrared Heating Lamp) is an adulterated and misbranded device. The firm failed to respond to the FDA 483.

The device was found adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820). Violations include: - Lack of trained personnel for design controls, complaint handling, and CAPA (21 CFR 820.25(a)). - No procedures for quality audits (21 CFR 820.22), design control (21 CFR 820.30(a)), corrective and preventative action (21 CFR 820.100(a)), labeling control (21 CFR 820.120), or acceptance activities (21 CFR 820.80(a)). - Inadequate packaging to prevent shipping damage (21 CFR 820.130). - Failure to ensure purchased products conform to requirements, lacking supplier evaluation procedures or contracts, and not knowing the production site (21 CFR 82