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FDA Dings Oregon Firm for Quality Failures

June 27, 2019

The FDA cited a Lake Oswego, Ore.-based drugmaker for quality control failures found during a March 11-15 inspection.

The agency official cited Kirkman Laboratories for six violations, from shoddy record keeping to not following its own written safety policies.

The facility had no written quality agreement spelling out the quality unit’s responsibilities for contract testing laboratories that conducted active pharmaceutical ingredient testing, finished drug product testing, in-process testing, stability testing and water testing for several sodium fluoride products.

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