Amish Origins Management, LLC
Form 483 issued January 10, 2025 · Worland, Wyoming
- Inspection
- Jan 7 – Jan 10, 2025
- Investigator
- Brittny C. Cargo
- Observations
- 6
- Pages
- 4
- FEI number
- 3013538760
In short: On January 10, 2025, FDA issued a Form 483 with 6 observations to Amish Origins Management, LLC in Worland, Wyoming (FEI 3013538760) after an inspection that ran Jan 7 – Jan 10, 2025. The investigator was Brittny C. Cargo. Most observations concern quality system and packaging & labeling.
At a glance
Observations span 4 systems, led by quality system.
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit…
- 02
Drug products do not bear an expiration date determined by appropriate stability data to assure they…
- 03
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 04
Each component is not tested for conformity with all appropriate written specifications for…
This inspection in context
Brittny C. Cargo
14 documents · 2022–2026
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Louisiana.
The firmAmish Origins Management, LLC history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.22(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Amish Origins Management, LLC?
FDA listed 6 observations on this Form 483, mostly about quality system, packaging & labeling and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Amish Origins Management, LLC?
Brittny C. Cargo is named on this Form 483, for the inspection of Jan 7 – Jan 10, 2025. Each investigator has a profile showing what they cite most.
When was Amish Origins Management, LLC inspected by FDA?
The inspection ran Jan 7 – Jan 10, 2025, and the Form 483 is dated January 10, 2025.
How do I get the full Form 483 for Amish Origins Management, 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.