An FDA Warning Letter notifies manufacturer about a violation

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Description: An FDA Warning Letter is a means for enforcing compliance among manufacturers in the regulated industry

FDA Warning Letter

A warning letter is defined by the US FDA as a correspondence that notifies regulated industry about violations that the FDA has documented during its inspections or investigations.

Generally a Warning Letter notifies the responsible party 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).

Warning letter must be issued only for those violations that have not been promptly acted upon by the responsible party and that can be enforced by the Federal Food, Drug, and Cosmetic Act. A warning letter is more of a prior notice of legal enforcement.

Background

FDA is authorized to perform inspections under the Federal Food, Drug and Cosmetic Act. These observations are recorded in Form FDA 483. These observations are shared with the facility and corrective action or response from the facility is sought. If there is no response or corrective action, then the FDA warning letter is sent out. 

Contents of a Warning Letter

The warning letter specifies the inspection details, requests response and corrective action to the violations, a warning statement of further action in case of failure to comply and provides the details of the impact of legal enforcement on the company.

Factors Influencing the Issuance of Warning Letter

Some of the factors that influence the FDA district offices’ as well as FDA centers’ decision on issuance of warning letter are

  • The compliance history of the company
  • The nature of violation and the risk associated with it as well as the impact of such a risk if occurs
  • The corrective actions taken by the company and the time frame.
  • Whether or not the corrective action has address all the concerns raised during the inspection.

Violations That May Warrant a Warning Letter are

labeling violations, computer applications violations, product advertising violations, adverse drug effects, investigational drug use violations, pharmacy compounding issues, tamper-evident packaging, cases involving CGMP (Center for Good Manufacturing Processes) charges such as drug manufacturing deficiency, Active pharmaceutical ingredient related issues or other issues related to dosage. Warning letters may also be issued if the company has not taken adequate prevention methods to avoid contamination while dealing with tissue or blood. Any other violations cited by other regulatory bodies, if not acted upon in a reasonable timeframe, may warrant an FDA warning letter.

Egregious Circumstances

When the circumstances have severe violation impact and if the FDA feels that immediate enforcement action is required, in such case warning letter is not issued and immediate enforcement action is carried out. Some of these circumstances are

  • A regular pattern of violation
  • Intentional violation
  • Violations leading to a possibility of death or injury
  • Willful violations such as felony

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