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Do you(drug manufacturers) get ready to prepare for the FDA inspection

Jason Dec 17,2018 Share this post:

The USA market is the biggest market in the world,many drug manufacturers have entered into this market,or want to enter into this market,but the FDA inspects the medicine manufacturers strictly,they will inspect the site check your factory,so you should know some notices about the FDA inspect.

When the FDA inquisitors are inspecting the site check your factory,if they find the problems(An FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.),they will require the manufacturers explain the problems by the "483" defect lettlers,if they don't get the satisfying answer about the problem,they will send the warning letter to the pharmaceutical manufacturers.

So today,I will tell u what the FDA check and the common defects.

  1. What the FDA check in the pharmaceutical manufacturers?The FDA inspect that whether the application materials is no difference with the dates of site documents record,and inspect whether the producing process observe the cGMP standard.They will emphasically inspect that department of quality Assurance,workshop,equipment department,material department,produced department,packaging department and laboratory.

  2. the common defects according to the past few years' warning letter

    1. the records and reports are not intact and exact,FDA require that any products produce,control and sale must be detailedly recorded,all components,drug containers,sealing parts and lables need be well recorded,the using and cleaning of instruments,producing and controling,produce saling,laboratory need be detailedly recorded,the integrality of these data is the key point of FDA checking.

    2. the control of the laboratory is irregular,The FDA requires laboratories develop specifications, standards, sampling methods, test procedures, or other laboratory control provisions,and the modifications to these contents require specialized departments to draft and review, and are approved by the quality department.

    3. the control of producing technologies and equipments using is irregular.

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