Annovex Pharma, Inc.
Form 483 issued May 27, 2026 · Lorton, Virginia
- Inspection
- May 27, 2026
- Investigator
- Christina K. Theodorou
- Observations
- 2
- Pages
- 4
- FEI number
- 3020928491
In short: On May 27, 2026, FDA issued a Form 483 with 2 observations to Annovex Pharma, Inc. in Lorton, Virginia (FEI 3020928491) after an inspection that ran May 27, 2026. The investigator was Christina K. Theodorou. Most observations concern facilities & equipment and quality system.
At a glance
Facilities & equipment and quality system account for 2 of 2 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Aseptic processing areas are deficient regarding systems for maintaining any equipment used to…
- 02
Records are not maintained so that data therein can be reviewed at least annually to evaluate…
This inspection in context
Christina K. Theodorou
19 documents · 2016–2026
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Pennsylvania.
The firmAnnovex Pharma, 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 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Annovex Pharma, Inc.?
FDA listed 2 observations on this Form 483, mostly about facilities & equipment and quality system. The opening words of each observation are shown on this page.
Who inspected Annovex Pharma, Inc.?
Christina K. Theodorou is named on this Form 483, for the inspection of May 27, 2026. Each investigator has a profile showing what they cite most.
When was Annovex Pharma, Inc. inspected by FDA?
The inspection ran May 27, 2026, and the Form 483 is dated May 27, 2026.
How do I get the full Form 483 for Annovex Pharma, 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.