Surefil, LLC
FDA inspection history in Grand Rapids, Michigan, 2021
- 1
- Form 483
Every document, by year
- Form 483
2021: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2021One Form 483, at Grand Rapids, Michigan.
Cited most
Across all Surefil observations on file
- 21 CFR 211.166(a)Stability testing2
- 21 CFR 211.165(b)Testing and release for distribution1
- 21 CFR 211.180(e)General requirements1
- 21 CFR 211.188(b)Batch production and control records1
- 21 CFR 211.22(d)Responsibilities of quality control unit1
The complete Surefil file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Grand Rapids, Michigan
One Form 483 · 2021 · 7 observations
Latest: Form 483, Nov 10, 2021 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2021-11-10 | 483 Form 483 | Grand Rapids, Michigan | 7 | $99 |
FEI number 3005649771 · most recent document Nov 10, 2021
About Surefil, LLC
How many FDA Form 483s has Surefil, LLC received?
FDA Intel has 1 Form 483 on file for Surefil, LLC; the most recent is dated Nov 10, 2021.
When was Surefil, LLC last inspected by FDA?
The most recent FDA inspection document on file for Surefil, LLC is a Form 483 dated Nov 10, 2021, for the site in Grand Rapids, Michigan.
What did FDA cite at Surefil, LLC?
The regulations cited most in the observations on file for Surefil, LLC are 21 CFR 211.166(a) (Stability testing), 2 times; 21 CFR 211.165(b) (Testing and release for distribution), 1 time; 21 CFR 211.180(e) (General requirements), 1 time.