Yaopharma Co., Ltd.
Form 483 issued March 29, 2019 · Chongqing, China
- Inspection
- Mar 25 – Mar 29, 2019
- Investigator
- Jose O. Hernandez
- Observations
- 1
- Pages
- 1
- FEI number
- 3008309828
In short: On March 29, 2019, FDA issued a Form 483 with 1 observation to Yaopharma Co., Ltd. in Chongqing, China (FEI 3008309828) after an inspection that ran Mar 25 – Mar 29, 2019. The investigator was Jose O. Hernandez. Most observations concern production; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
1 of 1 observations on this 483 concern production.
Most cited: 21 CFR 211.100 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written production and process control procedures are not followed in the execution of production and process…
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 firmYaopharma Co., Ltd. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Yaopharma Co., Ltd.?
FDA listed 1 observation on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected Yaopharma Co., Ltd.?
Jose O. Hernandez is named on this Form 483, for the inspection of Mar 25 – Mar 29, 2019. Each investigator has a profile showing what they cite most.
When was Yaopharma Co., Ltd. inspected by FDA?
The inspection ran Mar 25 – Mar 29, 2019, and the Form 483 is dated March 29, 2019.
How do I get the full Form 483 for Yaopharma 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.