By submitting this form, the submitter certifies that:
1. The establishment named in this registration is engaged in the manufacture, preparation, propagation, compounding, processing, packing, repacking, labeling, relabeling, or distribution of drug products.
2. All information provided in this form is true and accurate to the best of the submitter's knowledge.
3. The submitter is authorized to submit this registration on behalf of the owner or operator of the establishment.
4. The establishment agrees to permit FDA inspection as permitted under the Federal Food, Drug, and Cosmetic Act.
5. Under 18 U.S.C. §1001, anyone who makes a materially false, fictitious, or fraudulent statement to the U.S. Government is subject to criminal penalties.
6. This registration does not constitute FDA approval or endorsement of any drug product manufactured at this establishment.
7. This registration must be renewed annually during the period October 1 through December 31. Failure to renew registration may result in suspension.