in Pharmacy by (5.9k points)

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by (2.3k points)

FDA 483 is a form having observations given by FDA inspectors soon after inspection ends. Those observations are violated to the product and medical devices.

The FDA 483 should follow general principles are given below:

  1. Those observations listed should be significant and correlated to regulated products.
  2. Those observations are questionable should not mention in the form 483 but should discuss with firm management to reduce the problems those violated related to product.
  3. These observations should be clear.
  4. Observations should not repeated
  5. The FDA 483 observations should be legible
  6. Those observations should be ranked based on the significance.
  7. Those observations made during prior inspection are has not been corrected or a recurring observation.   
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