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.

  1. 2022One Form 483, at Bandar Baru Enstek, Malaysia.

Cited most

Across all site observations on file

The complete site file.

All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.

$99

The documents one by one, while the file is prepared

See the documents

Sites

Documents

1 on file, newest first
DateDocumentPrice
2022-09-07483 Form 483$99

Investigators on these documents

Santos E. Camara (1)

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.