Daewoong Pharmaceutical Co., Ltd. 35-14, Jeyakgongdan 4-Gil, Hyangnam-Eup
Form 483 issued November 17, 2017 · Hwaseong-Si, South Korea
- Inspection
- Nov 8 – Nov 17, 2017
- Investigators
- Alicia Mozzachio· Davinna Ligons· Ennan Guan
- Observations
- 3
- Pages
- 6
- FEI number
- 3012333115
In short: On November 17, 2017, FDA issued a Form 483 with 3 observations to Daewoong Pharmaceutical Co., Ltd. 35-14, Jeyakgongdan 4-Gil, Hyangnam-Eup in Hwaseong-Si, South Korea (FEI 3012333115) after an inspection that ran Nov 8 – Nov 17, 2017. The investigators were Alicia Mozzachio, Davinna Ligons, Ennan Guan, Thuy T. Nguyen and Viviana Matta. Most observations concern quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
This inspection in context
Alicia Mozzachio
2 documents · 2017–2018
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in South Korea.
The firmDaewoong Pharmaceutical Co., Ltd. 35-14, Jeyakgongdan 4-Gil, Hyangnam-Eup history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Daewoong Pharmaceutical Co., Ltd. 35-14, Jeyakgongdan 4-Gil, Hyangnam-Eup?
FDA listed 3 observations on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Daewoong Pharmaceutical Co., Ltd. 35-14, Jeyakgongdan 4-Gil, Hyangnam-Eup?
Alicia Mozzachio, Davinna Ligons, Ennan Guan, Thuy T. Nguyen and Viviana Matta are named on this Form 483, for the inspection of Nov 8 – Nov 17, 2017. Each investigator has a profile showing what they cite most.
When was Daewoong Pharmaceutical Co., Ltd. 35-14, Jeyakgongdan 4-Gil, Hyangnam-Eup inspected by FDA?
The inspection ran Nov 8 – Nov 17, 2017, and the Form 483 is dated November 17, 2017.
How do I get the full Form 483 for Daewoong Pharmaceutical Co., Ltd. 35-14, Jeyakgongdan 4-Gil, Hyangnam-Eup?
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