AG Essence, Inc
Form 483 issued February 26, 2025 · Sandston, Virginia
- Inspection
- Feb 18 – Feb 26, 2025
- Investigator
- David A. Oluwo
- Observations
- 5
- Pages
- 5
- FEI number
- 3009562273
In short: On February 26, 2025, FDA issued a Form 483 with 5 observations to AG Essence, Inc in Sandston, Virginia (FEI 3009562273) after an inspection that ran Feb 18 – Feb 26, 2025. The investigator was David A. Oluwo. Most observations concern production and facilities & equipment.
At a glance
Production and facilities & equipment account for 3 of 5 observations.
What FDA observed
Preview: the opening words of each observation- 01
Your firm failed to establish written procedures for production and process controls designed to assure that…
- 02
Procedures for the cleaning and maintenance of equipment are deficient regarding sufficient detail of the methods…
- 03
Specific identification tests are not conducted on components that have been accepted based on the…
- 04
Procedures designed to prevent objectionable microorganisms in drug products not required to be…
This inspection in context
David A. Oluwo
27 documents · 2017–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Maryland.
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 211.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at AG Essence, Inc?
FDA listed 5 observations on this Form 483, mostly about production, facilities & equipment and materials. The opening words of each observation are shown on this page.
Who inspected AG Essence, Inc?
David A. Oluwo is named on this Form 483, for the inspection of Feb 18 – Feb 26, 2025. Each investigator has a profile showing what they cite most.
When was AG Essence, Inc inspected by FDA?
The inspection ran Feb 18 – Feb 26, 2025, and the Form 483 is dated February 26, 2025.
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.