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Process Control Deficiencies Land Exemplar Pharmaceuticals a Form 483

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Exemplar Pharmaceuticals, a contract manufacturer of nasal sprays and other aerosol-based drugs, was handed a Form 483 for process control deficiencies tied to filling foul ups. In-process control procedures on the pressurized filling system at the Fall River, Mass., plant failed to prevent propellant loss, agency investigators found. Canister samples examined at the beginning and end of a batch raised content uniformity concerns, according to the form, handed to Exemplar after a March 21 inspection.
Drug Industry Daily