Shandong Anhong Pharmaceutical Co., Ltd.
Form 483 issued October 30, 2020 · Dezhou, China
- Inspection
- Oct 25 – Oct 30, 2020
- Investigator
- Chey Sorethan
- Observations
- 5
- Pages
- 4
- FEI number
- 3003877289
In short: On October 30, 2020, FDA issued a Form 483 with 5 observations to Shandong Anhong Pharmaceutical Co., Ltd. in Dezhou, Shandong (FEI 3003877289) after an inspection that ran Oct 25 – Oct 30, 2020. The investigator was Chey Sorethan. Most observations concern production and facilities & equipment.
At a glance
Production and facilities & equipment account for 3 of 5 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Processing areas are deficient regarding the system for cleaning…
- 02
Written procedures designed to prevent contamination of drug products purporting to be…
- 03
Laboratory controls do not include the establishment of scientifically sound and appropriate standards, sampling plans and…
- 04
The responsibilities and procedures applicable to the quality control unit…
This inspection in context
Chey Sorethan
1 document · 2020
Cites 211.110 (sampling and testing of in-process materials and drug products) more than any other section. Most of their documents are for sites in China.
The firmShandong Anhong 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 Shandong Anhong Pharmaceutical Co., Ltd.?
FDA listed 5 observations on this Form 483, mostly about production, facilities & equipment and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Shandong Anhong Pharmaceutical Co., Ltd.?
Chey Sorethan is named on this Form 483, for the inspection of Oct 25 – Oct 30, 2020. Each investigator has a profile showing what they cite most.
When was Shandong Anhong Pharmaceutical Co., Ltd. inspected by FDA?
The inspection ran Oct 25 – Oct 30, 2020, and the Form 483 is dated October 30, 2020.
How do I get the full Form 483 for Shandong Anhong 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.