Corden Pharma Boulder, Inc.
FDA inspection history in Boulder, Colorado, 2013 to 2019
- 2
- Form 483s
Every document, by year
- Form 483
2013: one Form 483; 2019: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2013One Form 483, at Boulder, Colorado.
- 2013The longest 483 on file: 3 observations over 3 pages at Boulder, Colorado.
- 2019One Form 483, at Boulder, Colorado.
Cited most
Across all Corden Pharma Boulder observations on file
- 21 CFR 211.160(a)General requirements1
- 21 CFR 211.192Production record review1
- 21 CFR 211.58Maintenance1
The complete Corden Pharma Boulder 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
Boulder, Colorado
Two Form 483s · 2013 to 2019 · 4 observations
Latest: Form 483, Feb 6, 2019 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2019-02-06 | 483 Form 483 | Boulder, Colorado | 1 | $99 |
| 2013-06-28 | 483 Form 483 | Boulder, Colorado | 3 | $99 |
Investigators on these documents
Elisa J. Beard (1)Jamie L. Dion (1)Kimberley Buytaert-Hoefen (1)Nayan J. Patel (1)
FEI number 1710165 · most recent document Feb 6, 2019
About Corden Pharma Boulder, Inc.
How many FDA Form 483s has Corden Pharma Boulder, Inc. received?
FDA Intel has 2 Form 483s on file for Corden Pharma Boulder, Inc.; the most recent is dated Feb 6, 2019.
When was Corden Pharma Boulder, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Corden Pharma Boulder, Inc. is a Form 483 dated Feb 6, 2019, for the site in Boulder, Colorado.
What did FDA cite at Corden Pharma Boulder, Inc.?
The regulations cited most in the observations on file for Corden Pharma Boulder, Inc. are 21 CFR 211.160(a) (General requirements), 1 time; 21 CFR 211.192 (Production record review), 1 time; 21 CFR 211.58 (Maintenance), 1 time.