Taking a closer look: are you prepared for an FDA allergen inspection? Manufacturers offer advice for success. (Exclusive Report).(Food and Drug Administration examines confectionery manufacturers)

OVER THE PAST FEW MONTHS, the Food and Drug Administration and state inspectors have intensified inspections of confectionery manufacturers. Although a FDA spokesperson terms them "regular inspections," they now include scrutiny of allergen handling and labeling procedures.

Fortunately for confectioners, the inspections "are following fairly closely the FDA's allergen inspection guidelines," says Alison Bodor, director of technical and regulatory affairs at the National Confectioners Association. She adds: "If companies have prepared for an inspection using those guidelines, they should be in good shape." (See "What The FDA Looks For" sidebar.)

Manufacturers that have had recent FDA inspections agree that the scouting credo "Be Prepared" is the best advice for a successful spot check.

At a minimum, this preparation should encompass implementing an effective sanitation program that includes proper cleaning methods, monitoring and record-keeping and audits. Implementing good manufacturing practices (GMPs) and control measures to prevent cross-contact between allergen- and non-allergen-containing products should also be in place.

Mike Bianco, vice-president of manufacturing for Jelly Belly Candy Co., which had both its Chicago and Fairfield, CA, plants inspected in the past two months, says the inspections were well-received because of Jelly Belly's preparedness in having readily available and complete documentation.

"You better have policies and procedures available for the inspector in terms of how you deal with the eight specific allergens," advises Bianco. " For example, cleanup logs, packaging logs and inspection logs."

He adds: "They're also going to ask for something in writing with your GMP process and any MSDSes (Manufacturer Safety Data Sheets)--they'll be looking for flavors and other things that might contain allergens."

Logan Jones, vice-president of operations for The Warrell Corp., agrees that paperwork and policy preparation are key to successful inspections.

"If a confectionery company is really serious about doing everything it possibly can, then it should develop an allergen control policy program and …