Form 483 · FEI 3005983287
Form 483 issued March 7, 2013 · Sungai Petani, Malaysia
- Inspection
- Mar 4 – Mar 7, 2013
- Investigator
- Kevia A. Gonzalez
- Observations
- 1
- Pages
- 1
- FEI number
- 3005983287
In short: On March 7, 2013, 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 4 – Mar 7, 2013. The investigator was Kevia A. Gonzalez. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.52 (washing and toilet facilities).
At a glance
1 of 1 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.52 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
On 03/06/13, during a random visit to the restrooms located in the production facility noted that…
This inspection in context
Kevia A. Gonzalez
1 document · 2013
Cites 211.52 (washing and toilet facilities) 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 211.52
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 211.52 (washing and toilet facilities). The opening words of each observation are shown on this page.
Who inspected an FDA-inspected site?
Kevia A. Gonzalez is named on this Form 483, for the inspection of Mar 4 – Mar 7, 2013. Each investigator has a profile showing what they cite most.
When was an FDA-inspected site inspected by FDA?
The inspection ran Mar 4 – Mar 7, 2013, and the Form 483 is dated March 7, 2013.
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.