FDA violations are forcing a Hudson Valley plant to implement mass layoffs and possibly shut down operations.

In March the FDA sent a warning letter to Dennis P. Borrello, the president and CEO of Ultra Seal Corporation that outlined a number of serious issues with their facilities in Highland and New Paltz.

Ultra Seal has been operating in the Hudson Valley since 1976. The contract packaging company began by packaging food products as well as other items into blister packs, bottles, tubes and more. In 1996 the company expanded to the production of tablets, capsules, ointments, creams gels and other products, manufacturing over-the-counter and prescription pharmaceuticals.

You have probably driven past their large facility on Route 299 in New Paltz, located next to The Living Seed.

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Between August and September of last year, an FDA inspection uncovered several "significant violations" that raised concerns about the quality of the items leaving the Ultra Seal facilities. According to the warning letter sent to the company, Ultra Seal was found by the FDA to be in violation of the Good Manufacturing Practice regulations for finished pharmaceuticals.

One of the violations involved improperly cleaned equipment that led to the cross-contamination of 22 lots of Pain Aid Extra Strength with the active pharmaceutical ingredient guaifenesin and 3 lots of cold tablets contaminated with caffeine. In both instances, the FDA says the company failed to properly investigate how the contamination happened and take steps to make sure it didn't happen again.

The investigation also uncovered insufficient testing methods in four batches of phenylephrine that are currently for sale on the market. The FDA warned that the company's failure to correct these issues has put the public at risk.

Your failure to comply... may affect the quality, safety, and efficacy of the drugs you test for your clients. It is essential that you understand your responsibility to operate in full compliance... and that you inform all your customers of any out-of-specification results or significant problems encountered during the testing of these drugs.

The letter ended with a stern warning that if Ultra Seal failed to address these issues the FDA could take legal action including "seizure, and injunction."

Assorted multicolored pills. Close up.
Assorted multicolored pills. Close up.
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According to paperwork filed by Ultra Seal with New York State, it appears that the FDA has taken action that has forced the company to cease operation, at least for now. Ultra Seal is laying off 86 workers, explaining the separations are "a result of findings of an evaluation (FDA mandated) of the company’s compliance with Current Good Manufacturing Practices." The mass layoff is expected to occur at three sites in New Paltz, Highland and Gardiner. The filing confirms that the layoffs are permanent.

It's unclear if Ultra Seal will attempt to continue operations. The notice says that the business "has not yet determined" if the sites will be closing.

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