Hospira Boulder, Inc.
FDA inspection history in Boulder, Colorado, 2011 to 2012
- 2
- Form 483s
Every document, by year
- Form 483
2011: one Form 483; 2012: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2011–12Two Form 483s, at Boulder, Colorado.
- 2012The longest 483 on file: 7 observations over 7 pages at Boulder, Colorado.
Cited most
Across all Hospira Boulder observations on file
- 21 CFR 211.100Written procedures; deviations3
- 21 CFR 211.67Equipment cleaning and maintenance3
- 21 CFR 211.192Production record review2
- 21 CFR 211.160General requirements1
- 21 CFR 211.165Testing and release for distribution1
The complete Hospira 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 · 2011 to 2012 · 12 observations
Latest: Form 483, May 11, 2012 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2012-05-11 | 483 Form 483 | Boulder, Colorado | 7 | $99 |
| 2011-06-21 | 483 Form 483 | Boulder, Colorado | 5 | $99 |
Investigators on these documents
Erika V. Butler (2)Kimberley A. Hoefeo (2)Zachery L. Miller (1)
FEI number 3005231248 · most recent document May 11, 2012
About Hospira Boulder, Inc.
How many FDA Form 483s has Hospira Boulder, Inc. received?
FDA Intel has 2 Form 483s on file for Hospira Boulder, Inc.; the most recent is dated May 11, 2012.
When was Hospira Boulder, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Hospira Boulder, Inc. is a Form 483 dated May 11, 2012, for the site in Boulder, Colorado.
What did FDA cite at Hospira Boulder, Inc.?
The regulations cited most in the observations on file for Hospira Boulder, Inc. are 21 CFR 211.100 (Written procedures; deviations), 3 times; 21 CFR 211.67 (Equipment cleaning and maintenance), 3 times; 21 CFR 211.192 (Production record review), 2 times.