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FDA Expands What’s In “Warning Letters”

The U.S. Food and Drug Administration (FDA) is making a contribution to government “transparency” with steps to improve its “Warning Letters” website.

In the past FDA has published the “Warning Letter” it sends out after an inspection finds problem at a food or drug facility.  Occasionally, it would also publish a response letter from a regulated company.

Since Sept. 1st, FDA is adding the “Close Out” letters it sends to companies after corrective actions have actually been taken.  Under that new policy, if violations are found on subsequent inspections, FDA can take enforcement action without further notice.

To see how this is all working out, we picked three “Warning Letters” issued on Sept. 9, 10, and 11 that were put up this past Tuesday as “recently issued.”

LaVale, MD-based Witmer Foods got a Sept. 9th letter from FDA’s Baltimore District Office about the inspections of its seafood processing/warehouse facility last May 20-21 and May 28.

The letter detailed “serious violations of the Seafood Hazard Analysis and Critical Control Point (HACCP) Regulation.”

“Accordingly, your Smoked Trout, raw unfrozen Mahi-Mahi, raw, unfrozen Tuna Fish; and pasteurized crabmeat are adulterated, in that they have been prepared, packed or held under insanitary conditions whereby they may have been rendered injurious to health,” the letter says.

The four-page letter details the violations and gives Witmer 15 days to respond.

Pelican Packers Inc. in Bellingham, WA got a “Warning Letter: sent out on Sept. 10th about inspections on June 11-12 and June 16-17 of its seafood processing facility.

The Seattle District Office told Pelican it had violated HACCP and “Accordingly, your albacore tuna in cans is adulterated, in that it has been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health,” FDA says.

Pelican was also given 15 days to correct the violations and respond to the letter.

On Sept. 11th, FDA’s Nashville Office sent the La Hacienda Tortilleria Inc–also in Nashville–a warning letter regarding an inspection that occurred on June 24-25, 2009.  The letter says: “Our investigators documented serious deviations from the regulations, which caused the tortilla products manufactured in your facility to be adulterated…”

The Nashville company’s four-page letter also outlines numerous violations, including a serious pest control problem including flies.  The building was not in sufficient repair and sanitary condition for a food-manufacturing facility.

La Hacienda too was given 15 days to respond.

FDA wants to tighten up the time between the inspection occurs and when “Warning Letters” about violations are sent out.  The new policy for  “Close Out” will show how long it takes FDA to bring about verified corrective actions by companies with violations.

FDA has also made some technical changes that help readers follow what is going on.  It’s now possible to browse “Warning Letters” by company, issuing office, subject, and by closeout letter.

Both drug and food company letters are found on the same site.

© Food Safety News