AG Essence, Inc
Form 483 issued May 14, 2015 · Richmond, Virginia
- Inspection
- Mar 30 – May 14, 2015
- Investigator
- Joey C. West
- Observations
- 25
- Pages
- 19
- FEI number
- 3009562273
In short: On May 14, 2015, FDA issued a Form 483 with 25 observations to AG Essence, Inc in Richmond, Virginia (FEI 3009562273) after an inspection that ran Mar 30 – May 14, 2015. The investigator was Joey C. West. Most observations concern laboratory controls and production & process controls; the most-cited regulation is 21 CFR 211.165 (testing and release for distribution).
At a glance
Observations span 4 systems, led by laboratory controls.
Most cited: 21 CFR 211.165 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written MDR procedures have not been…
- 02
Quality system procedures and instructions…
- 03
Procedures for corrective and preventive action…
- 04
Procedures for design control…
This inspection in context
Joey C. West
8 documents · 2009–2019
Cites 118.10 (recordkeeping requirements for the salmonella enteritidis (se) prevention plan) more than any other section. Most of their documents are for sites in Virginia.
The firmAG Essence, Inc history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.165
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at AG Essence, Inc?
FDA listed 25 observations on this Form 483, mostly about laboratory controls, production & process controls and production. The most-cited regulation is 21 CFR 211.165 (testing and release for distribution). The opening words of each observation are shown on this page.
Who inspected AG Essence, Inc?
Joey C. West is named on this Form 483, for the inspection of Mar 30 – May 14, 2015. Each investigator has a profile showing what they cite most.
When was AG Essence, Inc inspected by FDA?
The inspection ran Mar 30 – May 14, 2015, and the Form 483 is dated May 14, 2015.
How do I get the full Form 483 for AG Essence, 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.