Beijing HKKY Medical Tech. Co., Ltd.
Form 483 issued July 12, 2019 · Beijing, China
- Observations
- 2
- Pages
- 1
- FEI number
- 3013159466
In short: On July 12, 2019, FDA issued a Form 483 with 2 observations to Beijing HKKY Medical Tech. Co., Ltd. in Beijing, Beijing (FEI 3013159466). Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.165 (testing and release for distribution).
At a glance
2 of 2 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.165 (1×) · 211.160 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Each batch of drug product required to be free of objectionable microorganisms is not tested…
- 02
Procedures describing the calibration of instruments, apparatus, gauges and recording devices are…
This inspection in context
Questions about this 483
What did FDA find at Beijing HKKY Medical Tech. Co., Ltd.?
FDA listed 2 observations on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.165 (testing and release for distribution). The opening words of each observation are shown on this page.
When was Beijing HKKY Medical Tech. Co., Ltd. inspected by FDA?
This Form 483 is dated July 12, 2019.
How do I get the full Form 483 for Beijing HKKY Medical Tech. 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.