ABSTRACT
Under the current policy, the FDA may inspect an applicant’s facilities under any of the following scenarios:
1. Drug products that are difficult to manufacture and replicate 2. Drug products with a narrow therapeutic range, such as drugs used to treat epilepsy,
asthma, high blood pressure, and heart disease 3. Drugs that are new chemical entities 4. Drugs that represent a new dosage form for the applicant 5. Drugs to be manufactured by a firm with a history of noncompliance with cGMPs 6. Drugs to be manufactured by an applicant who has not previously submitted an NDA
or ANDA 7. Drugs to be manufactured by an applicant who has been manufacturing over-the-
counter products and who is seeking approval of its first prescription drug product 8. Other reasons as determined by the local district office
In addition to the above, a firm may receive a PAI for the filing of a supplement for NDA/ANDA changes:
1. Changes in the manufacturer or manufacturing site(s) 2. Changes in the supplier of the active ingredient 3. The introduction of a new dosage form 4. The use of new facilities or equipment or significant changes in manufacturing
facilities or equipment
For the suppliers listed in the application, a PAI is valid for 2 years for a domestic supplier and 3 to 4 years for a foreign supplier.
