Form 483 · FEI 3012094568
Form 483 issued August 30, 2023 · Yeonsu, South Korea
- Inspection
- Aug 28 – Aug 30, 2023
- Investigator
- Emily B. Camire
- Observations
- 1
- Pages
- 2
- FEI number
- 3012094568
In short: On August 30, 2023, FDA issued a Form 483 with 1 observation to an FDA-inspected site in Yeonsu, INCHEON (FEI 3012094568) after an inspection that ran Aug 28 – Aug 30, 2023. The investigator was Emily B. Camire. Most observations concern hCT/P; the most-cited regulation is 21 CFR 1271.270 (records).
At a glance
1 of 1 observations on this 483 concern hct/p.
Most cited: 21 CFR 1271.270(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Records were not detailed as necessary to provide a complete…
This inspection in context
Emily B. Camire
4 documents · 2023–2026
Cites 606.100 (standard operating procedures) more than any other section. Most of their documents are for sites in California.
The firmSite history
The site's inspection history, in date order.
Similar 483sOther sites cited under 1271.270(a)
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 hCT/P. The most-cited regulation is 21 CFR 1271.270 (records). The opening words of each observation are shown on this page.
Who inspected an FDA-inspected site?
Emily B. Camire is named on this Form 483, for the inspection of Aug 28 – Aug 30, 2023. Each investigator has a profile showing what they cite most.
When was an FDA-inspected site inspected by FDA?
The inspection ran Aug 28 – Aug 30, 2023, and the Form 483 is dated August 30, 2023.
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.