Review on Inspectional Observation and Warning Letters

  • Disha P Patel student
  • Niranjan Kanaki
  • Vinit Movaliya
  • Maitreyi Zaveri

Abstract

The Food and Drug Administration (FDA) facilitates authority for inspection in foreign countries which supply pharmaceutical products to the USA. So, the pharmaceutical companies in India must follow CGMP as per the FDA guidelines for the supply of pharma products. After the completion of inspection, FDA issues form 483, if it finds any deviations from CGMP as per the FDA guidelines. The main reason for form 483 observation is procedures are not fully followed in accordance with cGMP. In addition to FDA, regulatory body of India i.e., Central Drugs Standard Control Organization (CDSCO) also inspects manufacturing facilities in local and multinational companies, those inspection reports are released only in one of form 483 but not released on its websites publicly and it is reviewed by CDSCO representatives. The companies should respond to observations in form 483 within 15 working days. If the management fails to respond to observations within specified period of time, the FDA issues warning letters. If the response is unsatisfactory to the warning letters it may lead to further actions like suspension/cancellation of the manufacturing license, refuse to give product approval, import refusal of the products. Such an individual may be liable for a violation of the Act and, if found guilty, be subject to the penalties specified by the law.

Keywords: USFDA, Warning Letters, FDA Form 483, Inspectional observation, Enforcement actions

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References

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How to Cite
Patel, D. P., N. Kanaki, V. Movaliya, and M. Zaveri. “Review on Inspectional Observation and Warning Letters”. International Journal of Drug Regulatory Affairs, Vol. 11, no. 2, June 2023, pp. 64-67, doi:10.22270/ijdra.v11i2.597.

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