Shandong Anshun Pharmaceutical Co., Ltd.
Form 483 issued November 20, 2020 · Dezhou City, China
- Inspection
- Nov 16 – Nov 20, 2020
- Investigator
- Marcus A. Ray
- Observations
- 2
- Pages
- 3
- FEI number
- 3015326904
In short: On November 20, 2020, FDA issued a Form 483 with 2 observations to Shandong Anshun Pharmaceutical Co., Ltd. in Dezhou City, Shandong (FEI 3015326904) after an inspection that ran Nov 16 – Nov 20, 2020. The investigator was Marcus A. Ray. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.166 (stability testing).
At a glance
Laboratory controls and quality system account for 2 of 2 observations.
Most cited: 21 CFR 211.166 (1×) · 211.25 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The written stability program…
- 02
Analysts are not fully trained on analytical methods performed…
This inspection in context
Marcus A. Ray
14 documents · 2017–2025
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in China.
The firmShandong Anshun Pharmaceutical Co., Ltd. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.166
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Shandong Anshun Pharmaceutical Co., Ltd.?
FDA listed 2 observations on this Form 483, mostly about laboratory controls and quality system. The most-cited regulation is 21 CFR 211.166 (stability testing). The opening words of each observation are shown on this page.
Who inspected Shandong Anshun Pharmaceutical Co., Ltd.?
Marcus A. Ray is named on this Form 483, for the inspection of Nov 16 – Nov 20, 2020. Each investigator has a profile showing what they cite most.
When was Shandong Anshun Pharmaceutical Co., Ltd. inspected by FDA?
The inspection ran Nov 16 – Nov 20, 2020, and the Form 483 is dated November 20, 2020.
How do I get the full Form 483 for Shandong Anshun 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.