FDA WARNING_LETTER - Grandmas Food Products - June 20, 2014

The FDA inspected Grandmas Food Products in Kerala, India, on June 19-20, 2014, and found serious deviations from Emergency Permit Control (21 CFR 108) and Acidified Foods (21 CFR 114) regulations. The firm's July 23, 2014, response to the FDA-483 was deemed inadequate.

Significant violations include: 1. Failure to provide CFSAN with scheduled process information for acidified food products (e.g., curries, bitter gourd pickle) within 60 days of registration and before packing new products, as required by 21 CFR 108.25(c)(2). 2. Failure to register with FDA as an acidified foods manufacturer within 10 days of manufacturing, as required by 21 CFR 108.25(c)(1). The firm's provided form only updated their Food Facility Registration, not acidified food manufacturer registration. 3. Failure to establish scheduled processes for acidified foods by a qualified person with expert knowledge, as required by 21 CFR 114.83. 4. Failure to have plant personnel involved in acidification, pH control, heat treatment, or other critical factors under the operating supervision of an FDA-approved school attendee, as required by 21 CFR 108.25(f).