FDA WARNING_LETTER - West Food Company - March 30, 2014

The FDA issued a Warning Letter to West Food Company in Vietnam on October 2, 2014, following an inspection from March 27-30, 2014, of their low-acid canned food (LACF) and acidified food facility. The inspection revealed serious deviations from 21 CFR 108 (Emergency Permit Control), 21 CFR 113 (Thermally Processed Low-Acid Foods), and 21 CFR 114 (Acidified Foods). The firm's responses to the FDA-483 were deemed inadequate.

Key violations include failure to process acidified foods (tropical fruit salad) and LACF (baby corn) in conformity with scheduled processes, making unauthorized changes to scheduled processes without scientific substantiation or FDA notification, and failing to submit modifications within 30 days. Additionally, the firm failed to equip retorts with accurate temperature-indicating devices, initiated process timing before proper venting, and lacked established scheduled processes for acidified foods. The firm also failed to properly reprocess or evaluate food that deviated from scheduled processes.

These violations render the firm's products adulterated under Section 402(a)(4) of the Act. The FDA requires a written response within 15 working days detailing specific corrective actions and supporting documentation. Failure to comply may result in refusal of admission of products into the U.S. under Section 801(a) and placement on Detention Without Physical Examination (DWPE) via Import Alert #99-38. Reinspection-related fees may also be assessed. The company is responsible for ensuring full compliance with all applicable regulations.