Zhuhai Rundu Pharmaceutical Co., Ltd.
Form 483 issued September 20, 2019 · Zhuhai City, China
- Investigator
- Jeffrey P. Raimondi
- Observations
- 2
- Pages
- 1
- FEI number
- 3009954717
In short: On September 20, 2019, FDA issued a Form 483 with 2 observations to Zhuhai Rundu Pharmaceutical Co., Ltd. in Zhuhai City, Guangdong (FEI 3009954717). The investigator was Jeffrey P. Raimondi. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and facilities & equipment account for 2 of 2 observations.
Most cited: 21 CFR 211.192 (1×) · 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
Investigations into complaints are…
- 02
Schedules and procedures have not been established for the…
This inspection in context
Jeffrey P. Raimondi
40 documents · 2017–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in California.
The firmZhuhai Rundu 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 Zhuhai Rundu Pharmaceutical Co., Ltd.?
FDA listed 2 observations on this Form 483, mostly about quality system and facilities & equipment. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Zhuhai Rundu Pharmaceutical Co., Ltd.?
Jeffrey P. Raimondi is named on this Form 483. Each investigator has a profile showing what they cite most.
When was Zhuhai Rundu Pharmaceutical Co., Ltd. inspected by FDA?
This Form 483 is dated September 20, 2019.
How do I get the full Form 483 for Zhuhai Rundu 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.