Sam Chun Dang Pharm Co, Ltd
Form 483 issued October 25, 2019 · Hwaseong, South Korea
- Inspection
- Oct 17 – Oct 25, 2019
- Investigators
- Philip F. Istafanos· Yvins Dezan
- Observations
- 14
- Pages
- 27
- FEI number
- 3008425092
In short: On October 25, 2019, FDA issued a Form 483 with 14 observations to Sam Chun Dang Pharm Co, Ltd in Hwaseong, Gyeonggi (FEI 3008425092) after an inspection that ran Oct 17 – Oct 25, 2019. The investigators were Philip F. Istafanos and Yvins Dezan. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and laboratory controls account for 10 of 14 observations.
Most cited: 21 CFR 211.68(b) (2×)
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit are not in…
- 02
Employees are not given training in the particular operations they perform as part of their function…
- 03
Procedures describing the handling of written and oral complaints related to drug products are…
- 04
Failure to maintain a backup file of data entered into the…
This inspection in context
Philip F. Istafanos
13 documents · 2014–2025
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Canada.
The firmSam Chun Dang Pharm Co, Ltd history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.68(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Sam Chun Dang Pharm Co, Ltd?
FDA listed 14 observations on this Form 483, mostly about facilities & equipment, laboratory controls and quality system. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Sam Chun Dang Pharm Co, Ltd?
Philip F. Istafanos and Yvins Dezan are named on this Form 483, for the inspection of Oct 17 – Oct 25, 2019. Each investigator has a profile showing what they cite most.
When was Sam Chun Dang Pharm Co, Ltd inspected by FDA?
The inspection ran Oct 17 – Oct 25, 2019, and the Form 483 is dated October 25, 2019.
How do I get the full Form 483 for Sam Chun Dang Pharm Co, Ltd?
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