Food and Drugs Administration, (FDA) Haryana, India. |
Email ID: dahiya19@yahoo.com
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Last Updated on March 15, 2025 by The Health Master
Warning letter
The U.S. Food and Drug Administration (USFDA) plays a critical role in ensuring the safety and efficacy of drugs and issues warning letter after observing the deficiencies during the inspection of the pharma company.
One of the ways the USFDA achieves this is by enforcing Current Good Manufacturing Practice (CGMP) regulations.
CGMP refers to a set of standards that describe how a drug should be manufactured, processed, packed, labeled, stored, and tested to ensure its quality and safety.
A warning letter is a serious form of enforcement action that the USFDA can take against a pharmaceutical company that is not in compliance with CGMP regulations.
The warning letter details the violations that were observed during an inspection of the company’s manufacturing facility and gives the company a deadline to take corrective action.
Here are some of the common CGMP violations that can lead to a warning letter:
Failure to properly investigate deviations
Deviations are any instances in which a manufacturing process does not follow the established procedures.
The USFDA requires that companies investigate all deviations and take corrective action to prevent them from happening again.
Failure to adequately validate manufacturing processes
Validation is the process of demonstrating that a manufacturing process can consistently produce a product that meets its predetermined specifications.
The USFDA requires that companies validate all of their manufacturing processes.
Failure to have equipment of the appropriate design and suitability for use
The equipment used in a pharmaceutical manufacturing facility must be designed and maintained in a way that minimizes the risk of contamination.
Failure of the quality unit to exercise its responsibility to ensure that the API manufactured at the facility are in compliance with CGMP
The quality unit (QU) is responsible for overseeing all aspects of manufacturing to ensure that CGMP regulations are followed.
Failure to ensure all production deviations are reported and evaluated
All production deviations, regardless of how minor they may seem, must be reported and evaluated.
If a company receives a warning letter, it is important to take immediate action to address the violations observed during inspection.
The USFDA will follow up with the company to ensure that corrective actions have been taken.
If the company does not take corrective action, the USFDA may take further enforcement action, such as seizure of products or injunction.
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