British Drugmaker Cited for cGMP, Misbranding Violations

British drugmaker A Nelson has been cited in an FDA warning letter after an inspection found glass fragments in a batch of the company’s Clikpak drug vials.

Nelson had not identified a corrective and preventive action plan to reduce future occurrence, according to the July 26 warning letter, posted recently online. It also failed to determine if a potentially affected product was released for distribution.

Problems in A Nelson’s assembly process also caused some drugs to lack the correct amount of active ingredient, the FDA found during an inspection.

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