FDA WARNING_LETTER - United Nutrition Labs, Inc. - January 11, 2012

The FDA inspected United Nutrition Labs, Inc.'s dietary supplement manufacturing facility in Reedsville, PA, between December 2011 and January 2012. The inspection revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations for Dietary Supplements (21 CFR Part 111), rendering the firm's products, including various capsules, tablets, and powders, adulterated. Key deficiencies included the firm's failure to establish product specifications for finished dietary supplements (21 CFR 111.70(e)) and to conduct identity testing for dietary ingredients before use (21 CFR 111.75(a)). Additionally, Master Manufacturing Records lacked required sampling procedures (21 CFR 111.210(h)(2)), and instruments like the (b)(4) Infrared Spectroscopy were not properly calibrated (21 CFR 111.27(b)(2)-(3)). A critical concern was the firm's Quality Control Director not being qualified for assigned functions, as required by 21 CFR 111.12(c), a recurring issue since a previous inspection. The firm's January 9, 2012, response to the FDA Form 483 was deemed inadequate due to a lack of supporting documentation for proposed corrective actions, such as new SOPs, MMR changes, calibration, and personnel training. The FDA requires prompt corrective action and a written response within fifteen working days, including documentation, to prevent potential regulatory actions like seizure or injunction and the assessment of reinspection fees.