FDA WARNING_LETTER - La Estrellita Enterprises Incorporated - February 26, 2010

On February 18-26, 2010, the FDA inspected La Estrellita Enterprises, Inc. (dba La Estrellita Salsa Company) and found serious deviations from Acidified Food regulations (21 CFR Parts 108 and 114), rendering products like Red Salsa, Hot Green Jalapeno Salsa, and Green Vegetarian Chili adulterated.

Key violations include: 1. **Lack of Quality Control:** The firm did not standardize its pH meter with the appropriate pH 4.0 buffer before use, violating 21 CFR 114.80(a). 2. **Failure to Register and File Scheduled Processes:** The company failed to register with the FDA as an acidified food processor (21 CFR 108.25(c)(1)) and did not file scheduled processes for its Vegetarian Green Chile, Red Salsa, and Hot Green Jalapeno Salsa products (21 CFR 108.25(c)(2)). 3. **Absence of Established Scheduled Process:** No scheduled process was established by a qualified person for the aforementioned acidified foods, violating 21 CFR 114.83. 4. **Inadequate Record Keeping:** The firm failed to maintain production records for raw materials, packaging materials, and finished product evaluations (21 CFR 114.100(a) and (d)). 5.