Fujifilm Medical Systems U.S.A., Inc.
FDA inspection history in Wayne, New Jersey, 2015 to 2019
- 2
- Form 483s
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2015: one warning letter and one Form 483; 2019: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2015One warning letter and one Form 483, at Wayne, New Jersey.
- 2015The longest 483 on file: 5 observations over 6 pages at Wayne, New Jersey.
- 2019One Form 483, at Wayne, New Jersey.
Cited most
Across all Fujifilm Medical Systems U.S.A. observations on file
- 21 CFR 820.198(a)Complaint files3
- 21 CFR 806.10(a)(1)Reports of corrections and removals1
- 21 CFR 820.100(a)Corrective and preventive action1
- 21 CFR 820.75(a)Process validation1
The complete Fujifilm Medical Systems U.S.A. file.
All 3 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
Wayne, New Jersey
Two Form 483s and one warning letter · 2015 to 2019 · 6 observations
Latest: Form 483, Jul 2, 2019 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2019-07-02 | 483 Form 483 | Wayne, New Jersey | 1 | $99 |
| 2015-08-12 | Warning letter Warning letter | Wayne, New Jersey | — | $99 |
| 2015-04-09 | 483 Form 483 | Wayne, New Jersey | 5 | $99 |
Investigators on these documents
FEI number 2431293 · most recent document Jul 2, 2019
About Fujifilm Medical Systems U.S.A., Inc.
How many FDA Form 483s has Fujifilm Medical Systems U.S.A., Inc. received?
FDA Intel has 2 Form 483s on file for Fujifilm Medical Systems U.S.A., Inc.; the most recent is dated Jul 2, 2019.
When was Fujifilm Medical Systems U.S.A., Inc. last inspected by FDA?
The most recent FDA inspection document on file for Fujifilm Medical Systems U.S.A., Inc. is a Form 483 dated Jul 2, 2019, for the site in Wayne, New Jersey.
What did FDA cite at Fujifilm Medical Systems U.S.A., Inc.?
The regulations cited most in the observations on file for Fujifilm Medical Systems U.S.A., Inc. are 21 CFR 820.198(a) (Complaint files), 3 times; 21 CFR 806.10(a)(1) (Reports of corrections and removals), 1 time; 21 CFR 820.100(a) (Corrective and preventive action), 1 time.
Has Fujifilm Medical Systems U.S.A., Inc. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Fujifilm Medical Systems U.S.A., Inc.; the most recent is dated Aug 12, 2015.