Xinyu Pharmaceutical Co., Ltd.
Form 483 issued March 15, 2019 · SuZhou County, China
- Investigator
- Marijo B. Kambere
- Observations
- 4
- Pages
- 2
- FEI number
- 3006895831
In short: On March 15, 2019, FDA issued a Form 483 with 4 observations to Xinyu Pharmaceutical Co., Ltd. in SuZhou County, Anhui (FEI 3006895831). The investigator was Marijo B. Kambere. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
Facilities & equipment and production account for 3 of 4 observations.
Most cited: 21 CFR 211.68 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Observation 1: scanned text, readable in the full document.
- 02
Documentation system is…
- 03
The sys'em for maintaining and calibrating…
- 04
Validation of GMP-related computerized…
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 firmXinyu Pharmaceutical Co., Ltd. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.68
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Xinyu Pharmaceutical Co., Ltd.?
FDA listed 4 observations on this Form 483, mostly about facilities & equipment, production and quality system. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
Who inspected Xinyu Pharmaceutical Co., Ltd.?
Marijo B. Kambere is named on this Form 483. Each investigator has a profile showing what they cite most.
When was Xinyu Pharmaceutical Co., Ltd. inspected by FDA?
This Form 483 is dated March 15, 2019.
How do I get the full Form 483 for Xinyu 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.