The Food and Drug Administration found violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation in Vietnamese fish processor Hai Nam Co., Ltd.’s response to an earlier letter, it said in a warning letter dated June 18. FDA said it found Hai Nam’s HACCP plan to control histamine formation in mahi-mahi inadequate because: (1) it does not contain adequate critical limits; (2) its corrective action plans are not appropriate; (3) the plan does not list the food safety hazards of undeclared allergens; and (4) it does not list the critical control points.

On June 25 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

During the week of June 18-24, 2012, the Food and Drug Administration modified the following existing Import Alerts (not otherwise listed on the FDA's new and revised import alerts page) on the detention without physical examination of:

On June 22 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

On June 21 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

On June 20 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

The Food and Drug Administration issued its weekly Enforcement Report for June 20 that lists the status of recalls and field corrections for food, drugs, biologics, and devices. The report covers both domestic and foreign firms.

A premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) will be required for pacemaker pulse generators and pacemaker programmers, said the Food and Drug Administration in two final rules.

On June 19 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

The application form for the Food and Drug Administration’s Secure Supply Chain (SSC) pilot program was submitted for the Office of Management and Budget approval, it said, as well as forms for modification of the application, responses to terminations of participation in the program, and recordkeeping requirements. Comments on the proposed information collection are due to the Office of Management and Budget by July 20.