Binex Co., Ltd.
Form 483 issued June 20, 2024 · Incheon, South Korea
- Inspection
- Jun 12 – Jun 20, 2024
- Investigators
- Aditi S. Thakur· Della Shin· Thuy T. Nguyen
- Observations
- 4
- Pages
- 6
- FEI number
- 3014475240
In short: On June 20, 2024, FDA issued a Form 483 with 4 observations to Binex Co., Ltd. in Incheon, South Korea (FEI 3014475240) after an inspection that ran Jun 12 – Jun 20, 2024. The investigators were Aditi S. Thakur, Della Shin, Thuy T. Nguyen and Zachary Kraus. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
Observations span 4 systems, led by production.
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 lack of assurance that your drug substance manufacturing operations at facility are appropriately…
- 02
Your firm has not established adequate procedural controls to protect the electronic data acquisition and manufacturing…
- 03
Laboratory controls do not include the establishment of scientifically sound and appropriate standards designed to assure…
- 04
The responsibilities and procedures applicable to the Quality Unit are inadequate…
This inspection in context
Aditi S. Thakur
4 documents · 2018–2024
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmBinex Co., Ltd. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Binex Co., Ltd.?
FDA listed 4 observations on this Form 483, mostly about production, facilities & equipment and laboratory controls. 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 Binex Co., Ltd.?
Aditi S. Thakur, Della Shin, Thuy T. Nguyen and Zachary Kraus are named on this Form 483, for the inspection of Jun 12 – Jun 20, 2024. Each investigator has a profile showing what they cite most.
When was Binex Co., Ltd. inspected by FDA?
The inspection ran Jun 12 – Jun 20, 2024, and the Form 483 is dated June 20, 2024.
How do I get the full Form 483 for Binex 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.