Shandong Anxin Pharmaceutical Co., Ltd. (Laoling site)
Form 483 issued January 13, 2023 · Dezhou, China
- Inspection
- Jan 9 – Jan 13, 2023
- Investigator
- Tonia Barnard
- Observations
- 1
- Pages
- 2
- FEI number
- 3023338181
In short: On January 13, 2023, FDA issued a Form 483 with 1 observation to Shandong Anxin Pharmaceutical Co., Ltd. (Laoling site) in Dezhou, China (FEI 3023338181) after an inspection that ran Jan 9 – Jan 13, 2023. The investigator was Tonia Barnard. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
1 of 1 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.67 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your firm lacks a scientifically sound cleaning validation program for…
This inspection in context
Tonia Barnard
1 document · 2023
Cites 211.67 (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in China.
The firmShandong Anxin Pharmaceutical Co., Ltd. (Laoling site) 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 Anxin Pharmaceutical Co., Ltd. (Laoling site)?
FDA listed 1 observation on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected Shandong Anxin Pharmaceutical Co., Ltd. (Laoling site)?
Tonia Barnard is named on this Form 483, for the inspection of Jan 9 – Jan 13, 2023. Each investigator has a profile showing what they cite most.
When was Shandong Anxin Pharmaceutical Co., Ltd. (Laoling site) inspected by FDA?
The inspection ran Jan 9 – Jan 13, 2023, and the Form 483 is dated January 13, 2023.
How do I get the full Form 483 for Shandong Anxin Pharmaceutical Co., Ltd. (Laoling site)?
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.