FEI 1117550
FDA inspection history in Roanoke, Virginia, 2020 to 2025
- 2
- Form 483s
Every document, by year
- Form 483
2020: one Form 483; 2025: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2020One Form 483, at Roanoke, Virginia.
- 2025One Form 483, at Roanoke, Virginia.
- 2025The longest 483 on file: 9 observations over 6 pages at Roanoke, Virginia.
Cited most
Across all site observations on file
- 21 CFR 211.192Production record review2
- 21 CFR 211.68(a)Automatic, mechanical, and electronic equipment2
- 21 CFR 211.115(a)Reprocessing1
- 21 CFR 211.160(b)General requirements1
- 21 CFR 211.194(a)(8)Laboratory records1
The complete site file.
All 2 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
Roanoke, Virginia
Two Form 483s · 2020 to 2025 · 12 observations
Latest: Form 483, Mar 28, 2025 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-03-28 | 483 Form 483 | Roanoke, Virginia | 9 | $99 |
| 2020-02-28 | 483 Form 483 | Roanoke, Virginia | 3 | $99 |
Investigators on these documents
FEI number 1117550 · most recent document Mar 28, 2025
About FEI 1117550
How many FDA Form 483s has FEI 1117550 received?
FDA Intel has 2 Form 483s on file for FEI 1117550; the most recent is dated Mar 28, 2025.
When was FEI 1117550 last inspected by FDA?
The most recent FDA inspection document on file for FEI 1117550 is a Form 483 dated Mar 28, 2025, for the site in Roanoke, Virginia.
What did FDA cite at FEI 1117550?
The regulations cited most in the observations on file for FEI 1117550 are 21 CFR 211.192 (Production record review), 2 times; 21 CFR 211.68(a) (Automatic, mechanical, and electronic equipment), 2 times; 21 CFR 211.115(a) (Reprocessing), 1 time.