The FDA report - not good. In its report, the FDA said McNeil did not initiate "corrective and prevention action" after it had received 46 consumer complaints from June 2009 to April 2010 regarding foreign materials and black or dark specks in its drugs.
The agency cited the facility for not following quality controls and for not maintaining adequate lab facilities for the testing and approval of components and drug products. Source.
There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess.
Written production and process control procedures are not followed in the execution of production and process control function.
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