Ningxia Qiyuan Pharmaceutical Co., Ltd.
Form 483 issued June 28, 2019 · Yinchuan, China
- Inspection
- Jun 27 – Jun 28, 2019
- Investigator
- Marijo B. Kambere
- Observations
- 6
- Pages
- 3
- FEI number
- 3004341367
In short: On June 28, 2019, FDA issued a Form 483 with 6 observations to Ningxia Qiyuan Pharmaceutical Co., Ltd. in Yinchuan, Ningxia (FEI 3004341367) after an inspection that ran Jun 27 – Jun 28, 2019. The investigator was Marijo B. Kambere. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
Production and facilities & equipment account for 4 of 6 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Records are not completed…
- 02
The responsibility of the quality unit…
- 03
Precaution to avoid contamination when API are handled…
- 04
Cleaning procedures lack sufficient details to enable operators to clean each equipment…
This inspection in context
Marijo B. Kambere
11 documents · 2015–2021
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in China.
The firmNingxia Qiyuan Pharmaceutical Co., Ltd. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Ningxia Qiyuan Pharmaceutical Co., Ltd.?
FDA listed 6 observations on this Form 483, mostly about production, facilities & equipment and quality system. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected Ningxia Qiyuan Pharmaceutical Co., Ltd.?
Marijo B. Kambere is named on this Form 483, for the inspection of Jun 27 – Jun 28, 2019. Each investigator has a profile showing what they cite most.
When was Ningxia Qiyuan Pharmaceutical Co., Ltd. inspected by FDA?
The inspection ran Jun 27 – Jun 28, 2019, and the Form 483 is dated June 28, 2019.
How do I get the full Form 483 for Ningxia Qiyuan 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.