North China Pharmaceutical Huasheng Co., Ltd.
Form 483 issued August 10, 2018 · Shijiazhuang, China
- Inspection
- Aug 10, 2018
- Investigator
- Niketa Patel
- Observations
- 3
- Pages
- 3
- FEI number
- 3003001488
In short: On August 10, 2018, FDA issued a Form 483 with 3 observations to North China Pharmaceutical Huasheng Co., Ltd. in Shijiazhuang, Hebei (FEI 3003001488) after an inspection that ran Aug 10, 2018. The investigator was Niketa Patel. Most observations concern facilities & equipment and production.
At a glance
2 of 3 observations on this 483 concern facilities & equipment.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
During the validation failed to challenge the identified critical quality…
- 02
Failure to demonstrate that water used in the manufacture of your API is suitable…
- 03
Failure to clean and store equipment and utensils to prevent contamination or carry-over of a material…
This inspection in context
Niketa Patel
15 documents · 2016–2023
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in New Jersey.
The firmNorth China Pharmaceutical Huasheng 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 North China Pharmaceutical Huasheng Co., Ltd.?
FDA listed 3 observations on this Form 483, mostly about facilities & equipment and production. The opening words of each observation are shown on this page.
Who inspected North China Pharmaceutical Huasheng Co., Ltd.?
Niketa Patel is named on this Form 483, for the inspection of Aug 10, 2018. Each investigator has a profile showing what they cite most.
When was North China Pharmaceutical Huasheng Co., Ltd. inspected by FDA?
The inspection ran Aug 10, 2018, and the Form 483 is dated August 10, 2018.
How do I get the full Form 483 for North China Pharmaceutical Huasheng 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.