FDA-inspected site

FDA inspection history in Iskandar Puteri, Malaysia, 2018

1
Form 483

Every document, by year

  • Form 483

2018: one Form 483.

The story so far

Built from the dates and citations on the documents themselves.

  1. 2018One Form 483, at Iskandar Puteri, 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
2018-02-15483 Form 483$99

Investigators on these documents

Jose E. Melendez (1)Roger F. Zabinski (1)

About FDA-inspected site

How many FDA Form 483s has FDA-inspected site received?

FDA Intel has 1 Form 483 on file for FDA-inspected site; the most recent is dated Feb 15, 2018.

When was FDA-inspected site last inspected by FDA?

The most recent FDA inspection document on file for FDA-inspected site is a Form 483 dated Feb 15, 2018, for the site in Iskandar Puteri, Malaysia.

What did FDA cite at FDA-inspected site?

The regulations cited most in the observations on file for FDA-inspected site are 21 CFR 211.113 (Control of microbiological contamination), 1 time.