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FDA to issue report citing violations at Berger factory

February 25, 2013
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The Food and Drug Administration will issue a “Form 483″ to managers at the factory where the iconic Berger cookies are made, as part of an ongoing investigation, George Strait, special assistant communications at the federal agency’s Office of Regulatory Authority, confirmed today.

Form 483 is issued “at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgement may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts,” according to the FDA website.

This comes days after the The Sun first reported the Baltimore City Health Department shut down the Cherry Hill bakery responsible for the famous dark chocolate frosting-covered treats after it found the business was operating without a license.

The FDA website goes on to specify that Form 483 outlines observations when “in the investigator’s judgement, conditions or practices observed would indicate that any food, drug, device or cosmetic has been adulterated or is being prepared, packed, or held under conditions whereby it may become adulterated or rendered injurious to health.”

It was not immediately clear when the FDA inspected the facility. The city closed the factory Jan. 31.  The findings contained within the report were not yet available but will eventually be made public in a posting on the FDA’s site.

A city health department official previously told The Sun the oversight organization had no food-safety concerns with the cookie factory. Reached earlier today, health department officials were unable to respond to City Paper‘s questions in time for this blog post.

Anthony T. Bartlett, an attorney serving as spokesman for the DeBaufre family, owners of the bakery for more than 40 years, did not immediately return calls for comment.

Earlier this evening, The Sun reported the bakery is hoping to have its application for a license completed by Tuesday and quoted Bartlett as saying, “Our big goal is to reopen for business this week.” The Health Department re-emphasized it had no concerns about the safety of the cookies.

As for next steps, the FDA website says, “Form 483 notifies the company’s management of objectionable conditions.  At the conclusion of an inspection, the FDA Form 483 is presented and discussed with the company’s senior management.  Companies are encouraged to respond to the FDA Form 483 in writing with their corrective action plan and then implement that corrective action plan expeditiously.”

UPDATE on Feb. 26: After twice confirming, on Feb. 25th, that the FDA was going to issue a Form 483 to Bergers, George Strait today tells City Paper that the investigation is ongoing, but that he can no longer confirm that the form will be issued.

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