The Indian pharmaceutical industry is going through difficult times. One of the main problems is regulatory restrictions, particularly by the FDA (Food and Drug Administration).
The issuance of FDA Observe Form 483 for Observation, Warning Letters, and Import Warnings poses significant risks for Indian pharmaceutical companies exporting pharmaceuticals to the United States. Form 483 is usually the first indicator of a problem. You may search FDA 483 letters to know what exactly it is.
The FDA has the power to inspect overseas facilities that deliver drugs to the United States. Therefore, pharmaceutical manufacturers in India exporting to the US must comply with the Current Good Manufacturing Practices (cGMP) established by the FDA. FDA staff frequently visit the facility to review compliance.
The FDA issues Form 483 after examinations are complete. If deviations from cGMP are found, this is indicated on Form 483. The form identifies areas where the facility does not meet regulatory expectations. Then he introduced himself and discussed with company management.
Along with Form 483, the FDA also issues a Company Inspection Report (EIR) that specifies whether action should be taken.
The FDA requires a response to Form 483 observations within 15 business days. Although a written response is not required, it's best to avoid warning letters. The company must respond to the detailed observations with reasons for deficiencies and a corrective action plan. Each observation must be considered individually.
If management does not conclusively handle the observations on Form 483 within the allotted time, the FDA will issue a warning letter. Occasionally, if there is serious observation, the FDA may issue a warning letter without issuing form 483 and suspension or revocation of manufacturing authorization.