Novacyl
FDA inspection history in Roussillon, France, 2014 to 2016
- 2
- Form 483s
Every document, by year
- Form 483
2014: one Form 483; 2016: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2014–16Two Form 483s, at Roussillon, France.
- 2014The longest 483 on file: 4 observations over 2 pages at Roussillon, France.
Cited most
Across all Novacyl observations on file
- 21 CFR 211.192Production record review2
- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.142Warehousing procedures1
- 21 CFR 211.67Equipment cleaning and maintenance1
- 21 CFR 211.68Automatic, mechanical, and electronic equipment1
The complete Novacyl 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
Roussillon, France
Two Form 483s · 2014 to 2016 · 6 observations
Latest: Form 483, Jun 30, 2016 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2016-06-30 | 483 Form 483 | Roussillon, France | 2 | $99 |
| 2014-07-04 | 483 Form 483 | Roussillon, France | 4 | $99 |
Investigators on these documents
FEI number 3009804152 · most recent document Jun 30, 2016
About Novacyl
How many FDA Form 483s has Novacyl received?
FDA Intel has 2 Form 483s on file for Novacyl; the most recent is dated Jun 30, 2016.
When was Novacyl last inspected by FDA?
The most recent FDA inspection document on file for Novacyl is a Form 483 dated Jun 30, 2016, for the site in Roussillon, France.
What did FDA cite at Novacyl?
The regulations cited most in the observations on file for Novacyl are 21 CFR 211.192 (Production record review), 2 times; 21 CFR 211.100 (Written procedures; deviations), 1 time; 21 CFR 211.142 (Warehousing procedures), 1 time.