Sandoz GmbH
FDA inspection history in Broomfield, Colorado, 2011 to 2019
- 2
- Form 483s
Every document, by year
- Form 483
2011: one Form 483; 2019: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2011One Form 483, at Broomfield, Colorado.
- 2011The longest 483 on file: 11 observations over 9 pages at Broomfield, Colorado.
- 2019One Form 483, at Broomfield, Colorado.
Cited most
Across all Sandoz observations on file
- 21 CFR 211.160(a)General requirements3
- 21 CFR 211.192Production record review2
- 21 CFR 211.67(a)Equipment cleaning and maintenance2
- 21 CFR 211.110(a)Sampling and testing of in-process materials and drug products1
- 21 CFR 211.22(a)Responsibilities of quality control unit1
The complete Sandoz 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
Broomfield, Colorado
Two Form 483s · 2011 to 2019 · 14 observations
Latest: Form 483, Apr 16, 2019 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2019-04-16 | 483 Form 483 | Broomfield, Colorado | 3 | $99 |
| 2011-05-06 | 483 Form 483 | Broomfield, Colorado | 11 | $99 |
Investigators on these documents
Erika V. Butler (2)Kimberley A. Hoefeo (1)Zachery L. Miller (1)
FEI number 1717759 · most recent document Apr 16, 2019
About Sandoz GmbH
How many FDA Form 483s has Sandoz GmbH received?
FDA Intel has 2 Form 483s on file for Sandoz GmbH; the most recent is dated Apr 16, 2019.
When was Sandoz GmbH last inspected by FDA?
The most recent FDA inspection document on file for Sandoz GmbH is a Form 483 dated Apr 16, 2019, for the site in Broomfield, Colorado.
What did FDA cite at Sandoz GmbH?
The regulations cited most in the observations on file for Sandoz GmbH are 21 CFR 211.160(a) (General requirements), 3 times; 21 CFR 211.192 (Production record review), 2 times; 21 CFR 211.67(a) (Equipment cleaning and maintenance), 2 times.