Kyongbo Pharmaceutical Co., Ltd.
Form 483 issued December 6, 2019 · Asan, South Korea
- Inspection
- Dec 2 – Dec 6, 2019
- Investigator
- Stephanie A. Slater
- Observations
- 1
- Pages
- 2
- FEI number
- 3003773799
In short: On December 6, 2019, FDA issued a Form 483 with 1 observation to Kyongbo Pharmaceutical Co., Ltd. in Asan, Chungcheongnam-do (FEI 3003773799) after an inspection that ran Dec 2 – Dec 6, 2019. The investigator was Stephanie A. Slater. 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
There are deficiencies in your firm’s laboratory controls to ensure that data is fully secured and…
This inspection in context
Stephanie A. Slater
20 documents · 2015–2021
Cites 211.67 (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in California.
The firmKyongbo Pharmaceutical 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 Kyongbo Pharmaceutical Co., Ltd.?
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 Kyongbo Pharmaceutical Co., Ltd.?
Stephanie A. Slater is named on this Form 483, for the inspection of Dec 2 – Dec 6, 2019. Each investigator has a profile showing what they cite most.
When was Kyongbo Pharmaceutical Co., Ltd. inspected by FDA?
The inspection ran Dec 2 – Dec 6, 2019, and the Form 483 is dated December 6, 2019.
How do I get the full Form 483 for Kyongbo Pharmaceutical 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.