FDA warning letter: Eurofins SF Analytical Laboratories, Inc.

FDA issued a warning letter to David Riggs, President - EFSA Cluster at Eurofins SF Analytical Laboratories, Inc., about contract microbiological testing of drug components and products. FDA cites incomplete test records, results from damaged plates and gaps in secondary review.

Why it matters: FDA says incomplete microbiological records compromise quality review and leave questions about the accuracy of customer certificates of analysis.