Qilu Pharmaceutical Co., Ltd.
Form 483 issued February 22, 2018 · Jinan, China
- Inspection
- Feb 18 – Feb 22, 2018
- Investigator
- Marcellinus D. Dordunoo
- Observations
- 2
- Pages
- 2
- FEI number
- 3003674637
In short: On February 22, 2018, FDA issued a Form 483 with 2 observations to Qilu Pharmaceutical Co., Ltd. in Jinan, Shandong (FEI 3003674637) after an inspection that ran Feb 18 – Feb 22, 2018. The investigator was Marcellinus D. Dordunoo. Most observations concern quality system and facilities & equipment.
At a glance
Quality system and facilities & equipment account for 2 of 2 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Failure to adequately investigate non-conformances encountered during the manufacture of Active Pharmaceutical Ingredients, whether or not…
- 02
Temperature mapping studies of material storage areas and…
This inspection in context
Marcellinus D. Dordunoo
21 documents · 2017–2026
Cites 211.68 (automatic, mechanical, and electronic equipment) more than any other section. Most of their documents are for sites in Maryland.
The firmQilu Pharmaceutical Co., Ltd. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Qilu Pharmaceutical Co., Ltd.?
FDA listed 2 observations on this Form 483, mostly about quality system and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Qilu Pharmaceutical Co., Ltd.?
Marcellinus D. Dordunoo is named on this Form 483, for the inspection of Feb 18 – Feb 22, 2018. Each investigator has a profile showing what they cite most.
When was Qilu Pharmaceutical Co., Ltd. inspected by FDA?
The inspection ran Feb 18 – Feb 22, 2018, and the Form 483 is dated February 22, 2018.
How do I get the full Form 483 for Qilu 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.