Everlight Chemical Industrial Corporation Kuanyin II Plant
Form 483 issued April 10, 2015 · Taoyuan, Taiwan
- Inspection
- Apr 7 – Apr 10, 2015
- Investigator
- Justin A. Boyd
- Observations
- 12
- Pages
- 6
- FEI number
- 3003671545
In short: On April 10, 2015, FDA issued a Form 483 with 12 observations to Everlight Chemical Industrial Corporation Kuanyin II Plant in Taoyuan, Taiwan (FEI 3003671545) after an inspection that ran Apr 7 – Apr 10, 2015. The investigator was Justin A. Boyd. 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
The hand washing facilities located in the production facilities arc not…
This inspection in context
Justin A. Boyd
61 documents · 2010–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in India.
The firmEverlight Chemical Industrial Corporation Kuanyin II Plant history
The site's inspection history, in date order.
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 Everlight Chemical Industrial Corporation Kuanyin II Plant?
FDA listed 12 observations 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 Everlight Chemical Industrial Corporation Kuanyin II Plant?
Justin A. Boyd is named on this Form 483, for the inspection of Apr 7 – Apr 10, 2015. Each investigator has a profile showing what they cite most.
When was Everlight Chemical Industrial Corporation Kuanyin II Plant inspected by FDA?
The inspection ran Apr 7 – Apr 10, 2015, and the Form 483 is dated April 10, 2015.
How do I get the full Form 483 for Everlight Chemical Industrial Corporation Kuanyin II Plant?
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.