FDA WARNING_LETTER - AMK Food Export (Pvt) Ltd - December 10, 2013

On May 15, 2014, the FDA issued a Warning Letter to AMK Food Export (Pvt) Ltd following an inspection on December 9-10, 2013. The inspection revealed serious violations of regulations for Emergency Permit Control (21 CFR 108), Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers (21 CFR 113), Seafood Hazard Analysis and Critical Control Point (HACCP) (21 CFR 123), and Current Good Manufacturing Practice (21 CFR 110).

Key violations include: - **LACF Violations:** Failure to file scheduled processes for low-acid canned food (LACF) products, including (b)(4) glass jars, as required by 21 CFR 108.35(c)(2). Thermal processing records lacked required parameters (e.g., steam on/off times, venting time/temperature) per 21 CFR 113.100(a)(1). The firm failed to calibrate its mercury-in-glass thermometer (21 CFR 113.40(a)(1)) and did not conduct or document container closure examinations for glass jars (21 CFR 113.60(a)(2)). - **Seafood HACCP Violations:** The HACCP plan for (b)(4) did not