Jiangxi Synergy Pharmaceutical Co., Ltd.
Form 483 issued January 10, 2019 · Yichun, China
- Inspection
- Jan 7 – Jan 10, 2019
- Investigator
- Nicholas L. Hunt
- Observations
- 1
- Pages
- 1
- FEI number
- 3008465739
In short: On January 10, 2019, FDA issued a Form 483 with 1 observation to Jiangxi Synergy Pharmaceutical Co., Ltd. in Yichun, Jiangxi (FEI 3008465739) after an inspection that ran Jan 7 – Jan 10, 2019. The investigator was Nicholas L. Hunt. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
1 of 1 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.160 (1×) · 211.67 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is inadequate assurance OOP vater samples are representative of water used to…
This inspection in context
Nicholas L. Hunt
38 documents · 2017–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Arizona.
The firmJiangxi Synergy Pharmaceutical Co., Ltd. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Jiangxi Synergy Pharmaceutical Co., Ltd.?
FDA listed 1 observation 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 Jiangxi Synergy Pharmaceutical Co., Ltd.?
Nicholas L. Hunt is named on this Form 483, for the inspection of Jan 7 – Jan 10, 2019. Each investigator has a profile showing what they cite most.
When was Jiangxi Synergy Pharmaceutical Co., Ltd. inspected by FDA?
The inspection ran Jan 7 – Jan 10, 2019, and the Form 483 is dated January 10, 2019.
How do I get the full Form 483 for Jiangxi Synergy Pharmaceutical 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.