FDA Deficiency Letters

FDA Deficiency Letters

All manufacturers of finished products, packaging, and raw materials are required to abide by the law and adhere to strict compliance requirements. The U.S. Food and Drug Administration often finds deficiencies in laboratory testing. Such oversights can cost companies thousands to millions of dollars in delays in submissions and approvals, recalls, or interruptions in manufacturing.

The FDA review staff often identify the need for additional information prior to approving a product for the market, and often request such additional information in an FDA Deficiency Letter. If you have received an FDA Deficiency Letter and need help addressing the issues raised, please reach out to us. We have helped many clients test for the deficiencies identified by the FDA, and provide responsive reports addressing the deficiency letters within the required timeframe.

When submitting samples, please submit your sample along with the sample submittal forms. In order to prevent delays in testing, please specify the relevant tests, USP chapters, and microbial specifications you require on the form.

Some of the microbiology testing services we provide are listed below. If you are interested in microbiology testing not listed, please reach out to us. We will work with you to reach a testing solution.