UNION AGENER, INC.
Form 483 issued December 15, 2023 · Augusta, Georgia
- Investigator
- Veronica Fuentes
- Observations
- 3
- Pages
- 3
- FEI number
- 3003627565
In short: On December 15, 2023, FDA issued a Form 483 with 3 observations to UNION AGENER, INC. in Augusta, Georgia (FEI 3003627565). The investigator was Veronica Fuentes. Most observations concern laboratory controls and production.
At a glance
Laboratory controls and production account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observation- 01
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, sampling plans and…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
- 03
Procedures describing the handling of written and oral complaints related to drug products are…
This inspection in context
Veronica Fuentes
22 documents · 2016–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Georgia.
The firmUNION AGENER, INC. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.160(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at UNION AGENER, INC.?
FDA listed 3 observations on this Form 483, mostly about laboratory controls, production and quality system. The opening words of each observation are shown on this page.
Who inspected UNION AGENER, INC.?
Veronica Fuentes is named on this Form 483. Each investigator has a profile showing what they cite most.
When was UNION AGENER, INC. inspected by FDA?
This Form 483 is dated December 15, 2023.
How do I get the full Form 483 for UNION AGENER, 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.