FDA WARNING_LETTER - Dobake Bakeries, Inc. - November 02, 2010

The FDA inspected Dobake Bakeries, Inc. in Oakland, CA, from October 26 to November 2, 2010. The inspection and subsequent label review revealed several violations.

The "(b)(4) Raw Almond Croissants" and Elegant Pastries brand "Banana Walnut Loaf Cake" products are misbranded under Section 403(a)(1) of the Act [21 U.S.C. §343(a)(1)]. Their labels, "Raw Almond Croissants" and "Banana Walnut Loaf Cake," are false and misleading because the products contain artificial and natural flavors, not actual almond or banana. Labeling must comply with 21 CFR 101.22(i), requiring terms like "natural flavored" or "artificially flavored" if the characterizing ingredient is absent or insufficient.

Investigators also observed live insects (including apparent cockroaches) near production lines and apparent rodent pellets in the raw ingredients warehouse, indicating a failure to prevent pest adulteration, a violation of 21 CFR 110.35(c) and Sections 402(a)(3) and 402(a)(4) of the Act.

Additional labeling comments include: "Butter Vanilla Loaf Cake" labeling may be misleading if not all shortening is butter, per 21 CFR 101.22. Intervening material like "Manufactured on equipment