Quality · Your brand. Our science.
Every lot made in USA is tested and released by our quality unit before it ships. This page lists the tests, shows what our certificate of analysis contains, and gives the registration numbers you can look up yourself.
Made in USA[Tests run on every lot]
Product name, lot number and manufacture date. Each test with its method, the specification and the result. The laboratory, and the signature of the person who released the lot.
[Quality system statement] [Last FDA inspection]
| Credential | Number | Where to check it |
|---|---|---|
| FDA drug establishment registration | [FEI number] | FDA's drug establishment registration database |
| State manufacturer permit | [State permit number] | State Board of Pharmacy license lookup |
| Drug master file | [DMF number] | FDA's published list of drug master files |
| Laboratory accreditation | [Lab accreditation] | The accrediting body's directory |
Registration does not denote FDA approval.
The product name, lot number and manufacture date. Each test with its method, the specification and the result, covering identity, purity and content. The laboratory's name and the signature of the person who released the lot. A certificate without a lot number or methods cannot be checked.
Match the lot number on the certificate to the lot number on the container. Confirm the laboratory exists and, if it claims accreditation, look it up with the accrediting body. Then ask the manufacturer to confirm the certificate directly.
It means a drug establishment has registered with FDA as the law requires. It does not mean FDA has approved the establishment or its products. FDA's own regulation says registration does not denote approval.
No. FDA does not approve manufacturing facilities. Our plant is registered with FDA as a drug establishment, FEI [FEI number]. Registration does not denote approval.
Current Good Manufacturing Practice is the set of quality requirements FDA enforces for drug manufacturing. For active pharmaceutical ingredients, FDA's guidance is ICH Q7. FDA assesses compliance by inspecting facilities.
Last reviewed: