Janssen Biologics B.V.
FDA inspection history in Leiden, Netherlands, 2012 to 2014
- 2
- Form 483s
Every document, by year
- Form 483
2012: one Form 483; 2014: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2012–14Two Form 483s, at Leiden, Netherlands.
- 2012The longest 483 on file: 2 observations over 1 pages at Leiden, Netherlands.
Cited most
Across all Janssen Biologics B.V. observations on file
- 21 CFR 211.192Production record review2
- 21 CFR 211.113Control of microbiological contamination1
- 21 CFR 211.22Responsibilities of quality control unit1
The complete Janssen Biologics B.V. 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
Leiden, Netherlands
Two Form 483s · 2012 to 2014 · 3 observations
Latest: Form 483, Jul 11, 2014 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2014-07-11 | 483 Form 483 | Leiden, Netherlands | 1 | $99 |
| 2012-09-28 | 483 Form 483 | Leiden, Netherlands | 2 | $99 |
Investigators on these documents
FEI number 3002806632 · most recent document Jul 11, 2014
About Janssen Biologics B.V.
How many FDA Form 483s has Janssen Biologics B.V. received?
FDA Intel has 2 Form 483s on file for Janssen Biologics B.V.; the most recent is dated Jul 11, 2014.
When was Janssen Biologics B.V. last inspected by FDA?
The most recent FDA inspection document on file for Janssen Biologics B.V. is a Form 483 dated Jul 11, 2014, for the site in Leiden, Netherlands.
What did FDA cite at Janssen Biologics B.V.?
The regulations cited most in the observations on file for Janssen Biologics B.V. are 21 CFR 211.192 (Production record review), 2 times; 21 CFR 211.113 (Control of microbiological contamination), 1 time; 21 CFR 211.22 (Responsibilities of quality control unit), 1 time.