Yung Shin Pharm.Ind.(Kunshan) Co.,Ltd.
Form 483 issued March 15, 2019 · Suzhou, China
- Inspection
- Mar 11 – Mar 15, 2019
- Investigator
- Jose O. Hernandez
- Observations
- 2
- Pages
- 2
- FEI number
- 3004079584
In short: On March 15, 2019, FDA issued a Form 483 with 2 observations to Yung Shin Pharm.Ind.(Kunshan) Co.,Ltd. in Suzhou, China (FEI 3004079584) after an inspection that ran Mar 11 – Mar 15, 2019. The investigator was Jose O. Hernandez. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
2 of 2 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.160(a) (1×) · 211.160(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Deviations from written specifications and test…
- 02
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and standards designed…
This inspection in context
Jose O. Hernandez
12 documents · 2015–2020
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in New York.
The firmYung Shin Pharm.Ind.(Kunshan) Co.,Ltd. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.160(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Yung Shin Pharm.Ind.(Kunshan) Co.,Ltd.?
FDA listed 2 observations on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Yung Shin Pharm.Ind.(Kunshan) Co.,Ltd.?
Jose O. Hernandez is named on this Form 483, for the inspection of Mar 11 – Mar 15, 2019. Each investigator has a profile showing what they cite most.
When was Yung Shin Pharm.Ind.(Kunshan) Co.,Ltd. inspected by FDA?
The inspection ran Mar 11 – Mar 15, 2019, and the Form 483 is dated March 15, 2019.
How do I get the full Form 483 for Yung Shin Pharm.Ind.(Kunshan) 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.