TESTPAK REPACKAGING OF ORAL SOLID DOSAGE DRUGS DRAWS WARNING LETTER

Executive Summary

TESTPAK REPACKAGING OF ORAL SOLID DOSAGE DRUGS DRAWS WARNING LETTER from FDA's Newark, N.J. district office on Nov. 10. The letter followed an inspection of TestPak's Whippany, N.J. facility on Oct. 4, 5 and 13. The investigators found that TestPak "lacks appropriate documentation supporting the expiration dates applied to products repackaged into either unit dose or multi-dose packages." "Without the appropriate documentation," the letter states, TestPak is "required to do stability studies to support the expiration dates." Furthermore, the investigation found, "documentation is not kept showing retained samples are examined at least yearly for evidence of deterioration." TestPak responded to FDA on Nov. 24, saying it would get the necessary documentation from the manufacturers. The company said Dec. 1 that all other points addressed in the warning letter were answered to FDA's satisfaction. The agency letter also cites TestPak's failure "to retain a reserve sample for each repackaging operation" and censured the company for "not [following] its own [standard operating procedures] regarding label count discrepancies." The investigators also found TestPak's record-keeping procedures "inadequate," pointing out that: "obliteration of information was noted in various documents without identification of the person blanking out the information"; "record entries are not made as procedures occur"; and "labeling inventory control records are not completed." In addition, the letter states: "The Quality Assurance review of batch records prior to product release does not include all production records associated with production of the batch." Finally, FDA said TestPak did not include "the review of all packaging records" in its follow-up investigation of a mislabeling complaint.