Eagle Labs Inc.
Form 483 issued October 31, 2024 · Seminole, Florida
- Inspection
- Oct 3 – Oct 31, 2024
- Observations
- 4
- Pages
- 4
- FEI number
- 3005552050
In short: On October 31, 2024, FDA issued a Form 483 with 4 observations to Eagle Labs Inc. in Seminole, Florida (FEI 3005552050) after an inspection that ran Oct 3 – Oct 31, 2024. Most observations concern dietary supplement CGMP; the most-cited regulation is 21 CFR 111.70 (what specifications must you establish?).
At a glance
4 of 4 observations on this 483 concern dietary supplement cgmp.
What FDA observed
Preview: the opening words of each observation- 01
You did not establish product specifications for identity, purity, strength, composition…
- 02
For component(s) used in the manufacture of a dietary supplement, you did not establish identity specifications…
- 03
You did not ensure that the tests or examinations that you used to determine whether the…
- 04
Your batch production record did not…
This inspection in context
Questions about this 483
What did FDA find at Eagle Labs Inc.?
FDA listed 4 observations on this Form 483, mostly about dietary supplement CGMP. The most-cited regulation is 21 CFR 111.70 (what specifications must you establish?). The opening words of each observation are shown on this page.
When was Eagle Labs Inc. inspected by FDA?
The inspection ran Oct 3 – Oct 31, 2024, and the Form 483 is dated October 31, 2024.
How do I get the full Form 483 for Eagle Labs Inc.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.