Sichuan Qingmu Pharmaceutical Co., Ltd.
Form 483 issued September 7, 2021 · Meishan, China
- Inspection
- Sep 3 – Sep 7, 2021
- Investigator
- Sens Sous
- Observations
- 2
- Pages
- 2
- FEI number
- 3014747858
In short: On September 7, 2021, FDA issued a Form 483 with 2 observations to Sichuan Qingmu Pharmaceutical Co., Ltd. in Meishan, Sichuan (FEI 3014747858) after an inspection that ran Sep 3 – Sep 7, 2021. The investigator was Sens Sous. Most observations concern quality system; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
2 of 2 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 responsibilities and procedures applicable to the quality unit…
- 02
Written records are not always made of investigations into a failure of a batch or any…
This inspection in context
Sens Sous
1 document · 2021
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in China.
The firmSichuan Qingmu Pharmaceutical Co., Ltd. history
The site's inspection history, in date order.
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 Sichuan Qingmu Pharmaceutical Co., Ltd.?
FDA listed 2 observations 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 Sichuan Qingmu Pharmaceutical Co., Ltd.?
Sens Sous is named on this Form 483, for the inspection of Sep 3 – Sep 7, 2021. Each investigator has a profile showing what they cite most.
When was Sichuan Qingmu Pharmaceutical Co., Ltd. inspected by FDA?
The inspection ran Sep 3 – Sep 7, 2021, and the Form 483 is dated September 7, 2021.
How do I get the full Form 483 for Sichuan Qingmu 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.