FDA WARNING_LETTER - Lehman's Egg Service Inc. - May 28, 2008

On September 29, 2008, the FDA issued a Warning Letter to Lehman's Egg Service, Inc. following an inspection from May 21-28, 2008, of their acidified food manufacturing facility. The inspection revealed violations of the Federal Food, Drug, and Cosmetic Act (the Act) and regulations in 21 CFR Part 108 (Emergency Permit Control) and Part 114 (Acidified Foods), rendering their "Hannah's Red" and "Hannah's Clear" pickled eggs adulterated under section 402(a)(4) of the Act.

The primary violation was the failure to manufacture products in accordance with scheduled processes, specifically shipping products before the required (b)(4) ambient hold time expired, as mandated by 21 CFR Part 114.80(a)(1). The letter cited (b)(4) instances where products were shipped prematurely, including various lots of "Hannah's Clear" and "Hannah's Red" pickled eggs in May and March 2008.

Additionally, the firm failed to use water of adequate sanitary quality on food and food-contact surfaces, violating 21 CFR 110.37(a). The egg wash water was observed to be murky, not self-draining, and lacked residual chlorine, contrary to the firm's sanitation procedures.

The company was previously issued