Furman Foods Inc – FDA Warning Letter, Sep 10, 2010

On February 2, 2011, the FDA issued a Warning Letter to Furman Foods, Inc. following an inspection from August 30 to September 10, 2010, at their Northumberland, PA facility, which produces acidified and low-acid canned foods. The inspection revealed significant violations of 21 CFR Parts 114 (Acidified Foods), 113 (Low-Acid Canned Foods), and 110 (Current Good Manufacturing Practice).

Key violations include: 1. **Failure to establish a scheduled process for acidified food (21 CFR 114.83):** Specifically, for Rally's Chili with Beans, Lot (b)(4), the firm lacked a scheduled process established by a qualified expert. The existing process reference failed to identify the actual recommended process or critical factors, and no Least Sterilization Value (LSV) was submitted. 2. **Inadequate container integrity testing (21 CFR 114.80(a)(4)):** A hard swell pouch of Rally's Chili with Beans, Lot (b)(4), was found, and processing records showed no seam tests were conducted. The firm's response to increase pouch inspection frequency was deemed inadequate as it did not specify which inspections would increase or address the root cause of sealing issues. 3. **Failure to ensure proper closing machine performance and hermetic seal production (2