AG Essence, Inc
FDA inspection history across 2 sites, 2015 to 2025
- 2
- Form 483s
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2015: one Form 483; 2024: one warning letter; 2025: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2015One Form 483, at Richmond, Virginia.
- 2015The longest 483 on file: 25 observations over 19 pages at Richmond, Virginia.
- 2024–25One warning letter and one Form 483, at Sandston, Virginia.
Cited most
Across all AG Essence observations on file
- 21 CFR 211.100Written procedures; deviations2
- 21 CFR 211.165Testing and release for distribution2
- 21 CFR 211.67Equipment cleaning and maintenance2
- 21 CFR 211.84Testing and approval or rejection of components, drug product containers, and closures2
- 21 CFR 111.205What is the requirement to establish a master manufacturing record?1
The complete AG Essence file.
All 3 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Sandston, Virginia
One Form 483 and one warning letter · 2024 to 2025 · 5 observations
Latest: Form 483, Feb 26, 2025 →Richmond, Virginia
One Form 483 · 2015 · 25 observations
Latest: Form 483, May 14, 2015 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-02-26 | 483 Form 483 | Sandston, Virginia | 5 | $99 |
| 2024-06-14 | Warning letter Warning letter | Sandston, Virginia | — | $99 |
| 2015-05-14 | 483 Form 483 | Richmond, Virginia | 25 | $99 |
Investigators on these documents
FEI number 3009562273 · most recent document Feb 26, 2025
About AG Essence, Inc
How many FDA Form 483s has AG Essence, Inc received?
FDA Intel has 2 Form 483s on file for AG Essence, Inc; the most recent is dated Feb 26, 2025.
When was AG Essence, Inc last inspected by FDA?
The most recent FDA inspection document on file for AG Essence, Inc is a Form 483 dated Feb 26, 2025, for the site in Sandston, Virginia.
What did FDA cite at AG Essence, Inc?
The regulations cited most in the observations on file for AG Essence, Inc are 21 CFR 211.100 (Written procedures; deviations), 2 times; 21 CFR 211.165 (Testing and release for distribution), 2 times; 21 CFR 211.67 (Equipment cleaning and maintenance), 2 times.
Has AG Essence, Inc received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for AG Essence, Inc; the most recent is dated Jun 14, 2024.