FEI 3017604745
FDA inspection history in Bandar Baru Enstek, Malaysia, 2022
- 1
- Form 483
Every document, by year
- Form 483
2022: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2022One Form 483, at Bandar Baru Enstek, Malaysia.
Cited most
Across all site observations on file
- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.105Equipment identification1
- 21 CFR 211.67Equipment cleaning and maintenance1
The complete site file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Bandar Baru Enstek, Malaysia
One Form 483 · 2022 · 3 observations
Latest: Form 483, Sep 7, 2022 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-09-07 | 483 Form 483 | Bandar Baru Enstek, Malaysia | 3 | $99 |
Investigators on these documents
FEI number 3017604745 · most recent document Sep 7, 2022
About FEI 3017604745
How many FDA Form 483s has FEI 3017604745 received?
FDA Intel has 1 Form 483 on file for FEI 3017604745; the most recent is dated Sep 7, 2022.
When was FEI 3017604745 last inspected by FDA?
The most recent FDA inspection document on file for FEI 3017604745 is a Form 483 dated Sep 7, 2022, for the site in Bandar Baru Enstek, Malaysia.
What did FDA cite at FEI 3017604745?
The regulations cited most in the observations on file for FEI 3017604745 are 21 CFR 211.100 (Written procedures; deviations), 1 time; 21 CFR 211.105 (Equipment identification), 1 time; 21 CFR 211.67 (Equipment cleaning and maintenance), 1 time.