Annovex Pharma, Inc.
Form 483 issued September 6, 2024 · Lorton, Virginia
- Inspection
- Aug 26 – Sep 6, 2024
- Investigators
- Kara J. Wright· Tekalign Wondimu· Yaharn Su
- Observations
- 7
- Pages
- 5
- FEI number
- 3020928491
In short: On September 6, 2024, FDA issued a Form 483 with 7 observations to Annovex Pharma, Inc. in Lorton, Virginia (FEI 3020928491) after an inspection that ran Aug 26 – Sep 6, 2024. The investigators were Kara J. Wright, Tekalign Wondimu and Yaharn Su. Most observations concern quality system and production.
At a glance
Observations span 4 systems, led by quality system.
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
- 02
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 03
Aseptic processing areas are deficient regarding the system…
- 04
Written procedures are lacking which describe in sufficient detail the storage of components, diug…
This inspection in context
Kara J. Wright
9 documents · 2024–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Ohio.
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 211.113(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Annovex Pharma, Inc.?
FDA listed 7 observations on this Form 483, mostly about quality system, production and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Annovex Pharma, Inc.?
Kara J. Wright, Tekalign Wondimu and Yaharn Su are named on this Form 483, for the inspection of Aug 26 – Sep 6, 2024. Each investigator has a profile showing what they cite most.
When was Annovex Pharma, Inc. inspected by FDA?
The inspection ran Aug 26 – Sep 6, 2024, and the Form 483 is dated September 6, 2024.
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.