Deb USA Inc
FDA inspection history across 2 sites, 2018 to 2019
- 1
- Close-out
- 1
- Form 483
Every document, by year
- Close-out
- Form 483
2018: one Form 483; 2019: one close-out letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2018–19One Form 483 and one close-out letter, at Stanley, North Carolina and Racine, Wisconsin.
Cited most
Across all Deb USA observations on file
- 21 CFR 211.160(a)General requirements1
- 21 CFR 211.165(a)Testing and release for distribution1
- 21 CFR 211.182Equipment cleaning and use log1
- 21 CFR 211.194(a)Laboratory records1
- 21 CFR 211.22(d)Responsibilities of quality control unit1
The complete Deb USA 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
Racine, Wisconsin
One close-out letter · 2019
Latest: Close-out, Jun 11, 2019 →Stanley, North Carolina
One Form 483 · 2018 · 9 observations
Latest: Form 483, Oct 30, 2018 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2019-06-11 | Close-out Close-out letter | Racine, Wisconsin | — | $99 |
| 2018-10-30 | 483 Form 483 | Stanley, North Carolina | 9 | $99 |
Investigators on these documents
FEI number 3001606885 · most recent document Jun 11, 2019
About Deb USA Inc
How many FDA Form 483s has Deb USA Inc received?
FDA Intel has 1 Form 483 on file for Deb USA Inc; the most recent is dated Oct 30, 2018.
When was Deb USA Inc last inspected by FDA?
The most recent FDA inspection document on file for Deb USA Inc is a Form 483 dated Oct 30, 2018, for the site in Stanley, North Carolina.
What did FDA cite at Deb USA Inc?
The regulations cited most in the observations on file for Deb USA Inc are 21 CFR 211.160(a) (General requirements), 1 time; 21 CFR 211.165(a) (Testing and release for distribution), 1 time; 21 CFR 211.182 (Equipment cleaning and use log), 1 time.