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Understanding How FDA Warning Letters Can Hinder Your Company

January 30th, 2014 by

FDA Warning LetterUnder the Federal Food, Drug and Cosmetic Act, SEC. 704 (21 USC §374) “Factory Inspection” the United States Food and Drug Administration (FDA) is authorized to perform inspections of US and foreign facilities. Form FDA 483 (Inspection Observations) is used by FDA to document concerns discovered during inspections.

The 483 states that it “lists observations made by the FDA representative(s) during the inspection of your facility. They are inspectional observations and do not represent a final Agency determination regarding your compliance.”

A Prompt Response To Form FDA 483 May Prevent A Warning Letter

Under normal circumstances, a recipient of a 483 should respond to the FDA within 15 business days of receipt. Although this response is not compulsory, a good response may avoid the receipt of a Warning Letter. Responses should be comprehensive, well reasoned, documented and timely. Each observation of the 483 should be addressed individually.

The FDA defines a Warning Letter as:

“…a correspondence that notifies regulated industry about violations that FDA has documented during its inspections or investigations. Typically, a Warning Letter notifies a responsible individual or firm that the Agency considers one or more products, practices, processes, or other activities to be in violation of the Federal Food, Drug, and Cosmetic Act (the Act), its implementing regulations and other federal statutes. Warning Letters should only be issued for violations of regulatory significance, i.e., those that may actually lead to an enforcement action if the documented violations are not promptly and adequately corrected. A Warning Letter is one of the Agency’s principal means of achieving prompt voluntary compliance with the Act”.

FDA expects that companies will voluntarily comply with the law after receiving a Warning Letter by issuing prompt corrective and preventive actions. A response to a Warning Letter is mandatory. Upon receipt of the letter, the corrective and preventive actions must be submitted to FDA in the form of a plan. This plan describes how the company intends to immediately correct the observations made by the FDA during their inspection.

The response to a Warning Letter should:

  1. Be timely and understandable
  2. Provide objective evidence for the correction of observations
  3. Take the observations seriously, whereby it must be shown that all observations have been suitably addressed
  4. Address only those observations made during the inspection and not issues which may arise as a consequence of those observations
  5. Foresee a remediation plan, which must be drafted and submitted to FDA for its scrutiny and approval

The response should be made as soon as possible to the FDA and within 15 business days of receipt.

The FDA is vigilant in its efforts to protect consumers from fraudulent claims and defective products. Although some products may fail to work as advertised through no fault of the manufacturer, it can still result in an investigation into the safety of the product.

Therefore, it is vital your company incorporates the necessary measures and protocols across departments to investigate all stages of production prior to your products going to the market.

Reduce Your Risk of FDA Warning Letters

Within the life sciences community there is probably no enforcement actions dreaded more that receiving a 483 and/or a Warning Letter from the FDA. The seriousness of either type of enforcement should not be taken lightly.

There are a number of possible ways to avoid the risk of receiving a 483 or Warning Letter. These can include:

Investigate All Claims and Labels Before a Product Hits the Open Market

Increased scrutiny can help reduce the risk that a product is improperly labeled. In many cases, human error can result in the mis-labeling or mis-branding of a particular drug or medical device.

While FDA guidelines relate to how a study should be conducted or how oversight should be performed, a project manager should never assume that those working under him or her are doing things correctly. A trust-but-verify approach is the best way to ensure that all guidelines are adhered to.

Instituting Best Practices And Oversight Procedures Can Ensure Compliance

Receipt of a warning letter from the FDA means swift, yet verifiable, corrective actions must be taken. Fortunately, those involved with the project will have the chance to respond to the observations made during an inspection. Usually, those required to respond to FDA warning letters will be given a contact person to report to within 15 days. In some cases, you may be able to prove that your product is safe and your testing methods adhere to standards.

A Warning Letter from the FDA needs to be taken very seriously. If corrective actions are not taken, your company could face serious sanctions. However, FDA action can be avoided by following best practices and strict oversight procedures.

The international compliance consultant company, GxP-CC, provides consultative services for the pharmaceutical, medical devices and dental lab industries. Contact them to find out what your next steps should be if you’ve received a Warning Letter from the FDA or if you need help in attaining and maintaining compliance for your production processes and products.

About this author:

For over 15 years Mr. Francum has worked in regulated environments directing and orchestrating the various components involved in assuring compliance of the most stringent regulatory requirements. He is an internationally recognized expert and has extensive experience in over 25 countries including, but not limited to, the regions of North America, Latin America, Europe and the Middle East.

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