FDA hits Dominican Republic drug manufacturing plant with warning letter

FDA
The FDA issued a warning letter to Labocont Industrial following an inspection last year and cited the company for not taking more actions to fix the problems. (FDA)

The FDA issued a warning letter to Labocont Industrial following an inspection last year and cited the company for not taking more concrete actions in its follow-up response to the agency.

During the inspection conducted last June, the agency found Labocont wasn’t separating the production of its OTC drugs from its non-drug products. The FDA said the practice “presents an unacceptable risk of … contamination in other drug products manufactured at your facility.”

Labocont was told it could either dedicate separate manufacturing facilities for the different products and provide an implementation timeline, or it could conduct a full decontamination of the facility to continue production of a single product type and propose the plan for agency consideration prior to introducing products into the U.S. supply chain.

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Labocont was placed on the FDA’s Import Alert list in early February.

In its response letter to the FDA, the agency said the company “failed to commit to specific and comprehensive actions to address the violations observed during the inspection.”

Other violations in the warning letter include a lack of documented data obtained from assay analysis, invalidated analytical methods used for assay determinations, and uncalibrated and unverified instruments for performing laboratory tests.