Warning Letter: Concord Laboratories

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)].