Form 483 · FEI 3005983287
Form 483 issued March 23, 2018 · Sungai Petani, Malaysia
- Inspection
- Mar 19 – Mar 23, 2018
- Investigator
- Reoa A. Gates
- Observations
- 1
- Pages
- 1
- FEI number
- 3005983287
In short: On March 23, 2018, FDA issued a Form 483 with 1 observation to an FDA-inspected site in Sungai Petani, Kedah (FEI 3005983287) after an inspection that ran Mar 19 – Mar 23, 2018. The investigator was Reoa A. Gates. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
1 of 1 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.68 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
You have no documented evidence that the printer utilized to imprint the batch number, grade) manufacturing…
This inspection in context
Reoa A. Gates
1 document · 2018
Cites 211.68 (automatic, mechanical, and electronic equipment) more than any other section. Most of their documents are for sites in Malaysia.
The firmSite history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.68
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at an FDA-inspected site?
FDA listed 1 observation on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
Who inspected an FDA-inspected site?
Reoa A. Gates is named on this Form 483, for the inspection of Mar 19 – Mar 23, 2018. Each investigator has a profile showing what they cite most.
When was an FDA-inspected site inspected by FDA?
The inspection ran Mar 19 – Mar 23, 2018, and the Form 483 is dated March 23, 2018.
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.