Sandoz, Inc.
FDA inspection history in Wilson, North Carolina, 2011 to 2015
- 2
- Form 483s
Every document, by year
- Form 483
2011: one Form 483; 2015: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2011One Form 483, at Wilson, North Carolina.
- 2011The longest 483 on file: 8 observations over 11 pages at Wilson, North Carolina.
- 2015One Form 483, at Wilson, North Carolina.
Cited most
Across all Sandoz observations on file
- 21 CFR 211.110Sampling and testing of in-process materials and drug products3
- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.160General requirements1
- 21 CFR 211.165Testing and release for distribution1
- 21 CFR 211.22Responsibilities 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
Wilson, North Carolina
Two Form 483s · 2011 to 2015 · 10 observations
Latest: Form 483, Aug 13, 2015 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2015-08-13 | 483 Form 483 | Wilson, North Carolina | 2 | $99 |
| 2011-06-22 | 483 Form 483 | Wilson, North Carolina | 8 | $99 |
Investigators on these documents
Hai Lien T. Phung (1)Luis M. Burgos Medero (1)Seneca Toms (1)Tonshina R. Hall (1)
FEI number 3000210731 · most recent document Aug 13, 2015
About Sandoz, Inc.
How many FDA Form 483s has Sandoz, Inc. received?
FDA Intel has 2 Form 483s on file for Sandoz, Inc.; the most recent is dated Aug 13, 2015.
When was Sandoz, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Sandoz, Inc. is a Form 483 dated Aug 13, 2015, for the site in Wilson, North Carolina.
What did FDA cite at Sandoz, Inc.?
The regulations cited most in the observations on file for Sandoz, Inc. are 21 CFR 211.110 (Sampling and testing of in-process materials and drug products), 3 times; 21 CFR 211.100 (Written procedures; deviations), 1 time; 21 CFR 211.160 (General requirements), 1 time.