AMF Pharma LLC
Form 483 issued January 16, 2024 · Ontario, California
- Inspection
- Jan 8 – Jan 16, 2024
- Investigator
- Sparky L. Bartee
- Observations
- 4
- Pages
- 2
- FEI number
- 3010301210
In short: On January 16, 2024, FDA issued a Form 483 with 4 observations to AMF Pharma LLC in Ontario, California (FEI 3010301210) after an inspection that ran Jan 8 – Jan 16, 2024. The investigator was Sparky L. Bartee. 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 an identity…
- 02
You did not establish component specifications for…
- 03
You did not establish product specifications for the identity, purity, strength and composition of…
- 04
You did not establish…
This inspection in context
Sparky L. Bartee
1 document · 2024
Cites 111.70(b)(1) (what specifications must you establish?) more than any other section. Most of their documents are for sites in California.
The firmAMF Pharma LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 111.70(b)(1)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at AMF Pharma LLC?
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.
Who inspected AMF Pharma LLC?
Sparky L. Bartee is named on this Form 483, for the inspection of Jan 8 – Jan 16, 2024. Each investigator has a profile showing what they cite most.
When was AMF Pharma LLC inspected by FDA?
The inspection ran Jan 8 – Jan 16, 2024, and the Form 483 is dated January 16, 2024.
How do I get the full Form 483 for AMF Pharma LLC?
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.