Who is required to submit Facility Identification?
- Active Pharmaceutical Ingredients (API) facilities
- Finished Dosage Forms (FDF) facilities
- Positron Emission Tomography (PET) facilities
-
Clinical Bioequivalence (BE) or Bioavailability (BA) study sites
- In Vitro Bioequivalence Testing or Bioanalytical sites
- Contract API/FDF Analytical testing sites
- Contract Packaging sites
- Contract Repackaging Sites
For fiscal year 2013, identification information must be submitted by December 3, 2012. For each subsequent fiscal year, identification information must be submitted, updated, or reconfirmed on or before June 1 of the preceding fiscal year.
Under GDUFA, if a facility fails to self-identify, all FDF or API products manufactured at the facility and all FDFs containing APIs manufactured at the facility will be deemed misbranded.
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