FDA WARNING_LETTER - Vella Cheese Company of California Inc. - July 29, 2014

On November 6, 2014, the FDA issued a Warning Letter to Vella Cheese Company of California Inc. following an inspection from July 16-29, 2014. The inspection revealed violations of Section 404 of the Federal Food, Drug, and Cosmetic Act (the Act) and regulations for low-acid food products packaged in hermetically sealed containers (21 CFR 108 and 21 CFR 113).

The firm's "Bear Flag Brand High Moisture Monterey Jack Cheese" and "Bear Flag Brand Mezzo Secco Monterey Jack Cheese" were identified as low-acid food products due to unrefrigerated shipping conditions and FDA sample results showing pH above 4.6 and water activity above 0.85.

Key violations include: 1. Failure to register with the FDA as a commercial processor of low-acid foods, as required by 21 CFR 108.35(c)(1). 2. Failure to file scheduled process information with the FDA for the low-acid products, as required by 21 CFR 108.35(c)(2).

The FDA requires prompt corrective action. Failure to comply could lead to regulatory actions such as seizure, injunction, or an emergency permit requirement. The firm may also be assessed fees for re-inspection-related costs. A written response detailing corrective actions and documentation is required