Cit Co., Ltd.
Form 483 issued December 8, 2023 · Dangjin, South Korea
- Inspection
- Dec 4 – Dec 8, 2023
- Investigator
- Sonya M. Edmonds
- Observations
- 5
- Pages
- 3
- FEI number
- 3008160676
In short: On December 8, 2023, FDA issued a Form 483 with 5 observations to Cit Co., Ltd. in Dangjin, Chungnam (FEI 3008160676) after an inspection that ran Dec 4 – Dec 8, 2023. The investigator was Sonya M. Edmonds. Most observations concern laboratory controls and facilities & equipment; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
3 of 5 observations on this 483 concern laboratory controls.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 02
An adequate number of batches of each drug product are not tested to determine…
- 03
Verification of the suitability of the testing methods is deficient in that they are not documented…
- 0421 CFR 210
Employees are not given training in…
This inspection in context
Sonya M. Edmonds
12 documents · 2016–2025
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in North Carolina.
The firmCit Co., Ltd. history
The site's inspection history, in date order.
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 Cit Co., Ltd.?
FDA listed 5 observations on this Form 483, mostly about laboratory controls and 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 Cit Co., Ltd.?
Sonya M. Edmonds is named on this Form 483, for the inspection of Dec 4 – Dec 8, 2023. Each investigator has a profile showing what they cite most.
When was Cit Co., Ltd. inspected by FDA?
The inspection ran Dec 4 – Dec 8, 2023, and the Form 483 is dated December 8, 2023.
How do I get the full Form 483 for Cit Co., Ltd.?
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.