Chongqing Daxin Pharmaceutical Co., Ltd.
Form 483 issued January 29, 2015 · Shuitu Town, Beibei District, China
- Inspection
- Jan 26 – Jan 29, 2015
- Investigator
- Jeffrey D. Meng
- Observations
- 1
- Pages
- 2
In short: On January 29, 2015, FDA issued a Form 483 with 1 observation to Chongqing Daxin Pharmaceutical Co., Ltd. in Shuitu Town, Beibei District, China after an inspection that ran Jan 26 – Jan 29, 2015. The investigator was Jeffrey D. Meng. Most observations concern quality system; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.22 (1×) · 211.192 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The procedures and documentation to support the quality unit's…
This inspection in context
Jeffrey D. Meng
14 documents · 2010–2016
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Michigan.
The firmChongqing Daxin Pharmaceutical Co., Ltd. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Chongqing Daxin Pharmaceutical Co., Ltd.?
FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected Chongqing Daxin Pharmaceutical Co., Ltd.?
Jeffrey D. Meng is named on this Form 483, for the inspection of Jan 26 – Jan 29, 2015. Each investigator has a profile showing what they cite most.
When was Chongqing Daxin Pharmaceutical Co., Ltd. inspected by FDA?
The inspection ran Jan 26 – Jan 29, 2015, and the Form 483 is dated January 29, 2015.
How do I get the full Form 483 for Chongqing Daxin Pharmaceutical Co., Ltd.?
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