Janssen-Cilag Manufacturing, LLC
FDA inspection history in Gurabo, Puerto Rico, 2021
- 1
- Form 483
Every document, by year
- Form 483
2021: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2021One Form 483, at Gurabo, Puerto Rico.
Cited most
Across all Janssen-Cilag Manufacturing observations on file
- 21 CFR 211.160General requirements3
- 21 CFR 211.165Testing and release for distribution2
- 21 CFR 211.192Production record review2
- 21 CFR 211.198Complaint files1
- 21 CFR 211.22Responsibilities of quality control unit1
The complete Janssen-Cilag Manufacturing file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Gurabo, Puerto Rico
One Form 483 · 2021 · 13 observations
Latest: Form 483, Nov 23, 2021 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2021-11-23 | 483 Form 483 | Gurabo, Puerto Rico | 13 | $99 |
Investigators on these documents
Jose E. Melendez (1)Marian E. Ramirez (1)Miguel A. Martinez (1)
FEI number 3006244497 · most recent document Nov 23, 2021
About Janssen-Cilag Manufacturing, LLC
How many FDA Form 483s has Janssen-Cilag Manufacturing, LLC received?
FDA Intel has 1 Form 483 on file for Janssen-Cilag Manufacturing, LLC; the most recent is dated Nov 23, 2021.
When was Janssen-Cilag Manufacturing, LLC last inspected by FDA?
The most recent FDA inspection document on file for Janssen-Cilag Manufacturing, LLC is a Form 483 dated Nov 23, 2021, for the site in Gurabo, Puerto Rico.
What did FDA cite at Janssen-Cilag Manufacturing, LLC?
The regulations cited most in the observations on file for Janssen-Cilag Manufacturing, LLC are 21 CFR 211.160 (General requirements), 3 times; 21 CFR 211.165 (Testing and release for distribution), 2 times; 21 CFR 211.192 (Production record review), 2 times.