Jiangsu Grand Xinyi Pharmaceutical Co., Ltd.
Form 483 issued September 12, 2019 · Yancheng, China
- Inspection
- Sep 9 – Sep 12, 2019
- Investigator
- Michael A. Charles
- Observations
- 6
- Pages
- 3
- FEI number
- 3011070603
In short: On September 12, 2019, FDA issued a Form 483 with 6 observations to Jiangsu Grand Xinyi Pharmaceutical Co., Ltd. in Yancheng, Jiangsu (FEI 3011070603) after an inspection that ran Sep 9 – Sep 12, 2019. The investigator was Michael A. Charles. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Facilities & equipment and laboratory controls account for 4 of 6 observations.
Most cited: 21 CFR 211.67 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Laboratory controls do not include the establishment of scientifically sound and appropriate procedures designed ‘to assure…
- 02
Written records of investigations into unexplained discrepancies…
- 03
Written procedures for cleaning fail to include description in sufficient detail of methods, equipment and materials…
- 04
Procedures for the maintenance of manufacturing equipment are not always followed regarding…
This inspection in context
Michael A. Charles
29 documents · 2013–2024
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Colorado.
The firmJiangsu Grand Xinyi Pharmaceutical Co., Ltd. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Jiangsu Grand Xinyi Pharmaceutical Co., Ltd.?
FDA listed 6 observations on this Form 483, mostly about facilities & equipment, laboratory controls and quality system. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Jiangsu Grand Xinyi Pharmaceutical Co., Ltd.?
Michael A. Charles is named on this Form 483, for the inspection of Sep 9 – Sep 12, 2019. Each investigator has a profile showing what they cite most.
When was Jiangsu Grand Xinyi Pharmaceutical Co., Ltd. inspected by FDA?
The inspection ran Sep 9 – Sep 12, 2019, and the Form 483 is dated September 12, 2019.
How do I get the full Form 483 for Jiangsu Grand Xinyi Pharmaceutical Co., Ltd.?
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