Oriental Packing Co., Inc. – FDA Warning Letter, Jan 4, 2012

This FDA Warning Letter, FLA-12-27, dated March 19, 2012, was issued to Oriental Packing Co., Inc. following an inspection of their spice processing facility in Miami, FL, conducted on December 19-20, 22, 2011, and January 4, 2012. The inspection revealed serious violations of the Current Good Manufacturing Practice (CGMP) regulation for foods (21 CFR Part 110), rendering their products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act due to insanitary conditions.

Key violations include: 1. **Failure to Clean and Sanitize Food Contact Surfaces (21 CFR 110.35(d)):** Equipment (mixers, storage/transport containers, package filling machines) used for both non-allergenic and allergenic (wheat-containing) products was not routinely cleaned or sanitized between uses, leading to cross-contamination risk. Examples included uncleaned containers used for different products and spice residue on mixer surfaces. 2. **Inadequate Production Procedures to Prevent Contamination (21 CFR 110.80):** Equipment was not adequately cleaned, and raw materials/packaging were stored improperly. A damaged mixer chute was held with adhesive tape and had spice residue. Raw ingredients were in open, unsealed bags, and plastic