FDAnews Drug Daily Bulletin
Pharmaceuticals / Inspections and Audits

New Jersey Firm Warned for Quality Deficiencies

Jan. 4, 2018
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C.O. Truxton drew a warning letter from the FDA for drug repackaging, labeling, complaint handling and product distribution.

An inspection from April to June at the firm’s Bellmawr, New Jersey facility found the drug repackaging operation had no quality control unit or written procedures detailing production or quality unit responsibilities. It also lacked written procedures to ensure correct labels and packaging materials were used.

Agency inspectors observed a container of 30mg Phenobarbital tablets mislabeled as Phenobarbital tablets USP 15mg and noted the firm did not have records of the repackaging operation.

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