Lamberts Inc – FDA Warning Letter, Mar 5, 2010

On March 2-5, 2010, the FDA inspected Lambert's Inc.'s bottled water, coffee roasting, and flavoring processing facility in Memphis, Tennessee. The inspection revealed serious violations of 21 CFR 110 (Current Good Manufacturing Practice), 21 CFR 129 (Bottled Drinking Water), and 21 CFR 165 (Beverages). The company's bottled water and coffee products were deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) due to insanitary conditions.

Key violations included: - Failure to sample and inspect containers/closures for contamination quarterly (21 CFR 129.80(f)). - Failure to conduct weekly bacteriological testing of bottled water (21 CFR 129.80(g)(1)). - Failure to conduct annual chemical, physical, and radiological testing of bottled water (21 CFR 129.80(g)(2)). - Failure to maintain required records for two years, including equipment inspections, mechanical washer performance, cleaning/sanitizing solution testing, sanitizing agent intensity/duration, and finished product testing (21 CFR 129.80(h)). - Inadequate sanitizing operations for product water-contact surfaces (21 CFR 129.80(d)).