Henan Kangdi Medical Devices Co. Ltd.
Form 483 issued March 7, 2019 · ZHOUKOU, China
- Inspection
- Mar 4 – Mar 7, 2019
- Investigator
- Marcellinus D. Dordunoo
- Observations
- 7
- Pages
- 3
- FEI number
- 3009271465
In short: On March 7, 2019, FDA issued a Form 483 with 7 observations to Henan Kangdi Medical Devices Co. Ltd. in ZHOUKOU, Henan (FEI 3009271465) after an inspection that ran Mar 4 – Mar 7, 2019. The investigator was Marcellinus D. Dordunoo. Most observations concern laboratory controls and materials; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
Observations span 4 systems, led by laboratory controls.
Most cited: 21 CFR 211.68 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 02
The written stability program for drug products does not…
- 03
Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity…
- 04
Fach container or grouping of containers of components is not examined visually upon receipt and before…
This inspection in context
Marcellinus D. Dordunoo
21 documents · 2017–2026
Cites 211.68 (automatic, mechanical, and electronic equipment) more than any other section. Most of their documents are for sites in Maryland.
The firmHenan Kangdi Medical Devices 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
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Henan Kangdi Medical Devices Co. Ltd.?
FDA listed 7 observations on this Form 483, mostly about laboratory controls, materials 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 Henan Kangdi Medical Devices Co. Ltd.?
Marcellinus D. Dordunoo is named on this Form 483, for the inspection of Mar 4 – Mar 7, 2019. Each investigator has a profile showing what they cite most.
When was Henan Kangdi Medical Devices Co. Ltd. inspected by FDA?
The inspection ran Mar 4 – Mar 7, 2019, and the Form 483 is dated March 7, 2019.
How do I get the full Form 483 for Henan Kangdi Medical Devices 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.