Warning Letter: Concord Laboratories

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ePT--the Electronic Newsletter of Pharmaceutical Technology

The US Food and Drug Administration's New Jersey District Office issued a Warning Letter to Concord Laboratories (Fairfield, NJ), citing the company for manufacturing three generic products without an ANDA, and for ten deviations from current good manufacturing practices.

This week, the US Food and Drug Administration posted a July 11 Warning Letter (www.fda.gov/foi/warning_letters/g5973d.htm) from its New Jersey District office (Parsippany, NJ) to Concord Laboratories (Fairfield, NJ, www.concordlabsinc.com).

The five-page letter cites Concord for manufacturing colchicine tablets, hyoscyamine sulfate tablets, and nitroglycerine tablets without holding an NDA or ANDA, and for ten deviations from current good manufacturing practices, including:


  • Not keeping written records for some discrepancy investigations, and not extending investigations to additional batches of the product [21 CFR § 211.192]. Instances included loose caps on bottles of nitroglycerine tablets, omitting an assay test when investigating complaints that nitroglycerine tablets did not dissolve properly, failure to investigate or do follow-up assays after an HPLC malfunction, and failure to document the impact of power failures on product testing.

  • Omitting signatures from some laboratory test records [21 CFR § 211.194(a)(7)].

  • Not recording names of staffers making test-method modifications [21 CFR§ 211.194(b)].

  • Using a common password for all users, and thus failing to control access to computer records and maintain an audit trail [21 CFR § 211.68(b)].

  • Contracting certain analytical tests to laboratories that had not been qualified by Concord's quality unit, as required by company procedures [21 CFR § 211.22(d)].

  • Failing to monitor the ventilation system to confirm sufficient pressure to isolate manufacturing rooms, corridors, and pharmacy rooms [21 CFR § 211.42(c)(5)].

  • Failing to verify that the air system purification prevents cross contamination [21 CFR § 211. 46(c)].

  • Not establishing acceptable-yield specifications needed for master production and control records for each drug product [21 CFR § 211.186(b)(7)].

  • Using monitoring devices (sensors for humidity, water-pressure, or water quality) whose performance had not been demonstrated or specified [21 CFR § 211.160(b)(4)].

  • Failing to maintain a packaging hopper, which was found to be cracked, creating a possibility of cross-contamination [21 CFR § 211.67(a)].