Form 483 · FEI 3011248248
Form 483 issued September 24, 2021 · Iskandar Puteri, Malaysia
- Inspection
- Sep 13 – Sep 24, 2021
- Investigators
- Wayne Seifert· Yetao Jin
- Observations
- 6
- Pages
- 4
- FEI number
- 3011248248
In short: On September 24, 2021, FDA issued a Form 483 with 6 observations to an FDA-inspected site in Iskandar Puteri, Malaysia (FEI 3011248248) after an inspection that ran Sep 13 – Sep 24, 2021. The investigators were Wayne Seifert and Yetao Jin. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Facilities & equipment and production account for 3 of 5 observations.
Most cited: 21 CFR 211.67 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
: essel and . . U/mL vial ml) have been r--:-.,.,-_,..,.--,.....---~ and distribution system is not…
- 02
tic behavior and monitoring…
- 04
Facilities and equipment are not adequately validated…
- 05
Cleaning validations in support of drug…
This inspection in context
Wayne Seifert
37 documents · 2010–2025
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in Germany.
The firmSite history
All 6 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at an FDA-inspected site?
FDA listed 6 observations on this Form 483, mostly about facilities & equipment, production and laboratory controls. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected an FDA-inspected site?
Wayne Seifert and Yetao Jin are named on this Form 483, for the inspection of Sep 13 – Sep 24, 2021. Each investigator has a profile showing what they cite most.
When was an FDA-inspected site inspected by FDA?
The inspection ran Sep 13 – Sep 24, 2021, and the Form 483 is dated September 24, 2021.
How do I get the full Form 483 for an FDA-inspected site?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.