Zhejiang Charioteer Pharmaceutical Co., Ltd.
Form 483 issued January 18, 2018 · Taizhou, China
- Inspection
- Jan 15 – Jan 18, 2018
- Investigator
- Michael A. Charles
- Observations
- 2
- Pages
- 2
- FEI number
- 3002808516
In short: On January 18, 2018, FDA issued a Form 483 with 2 observations to Zhejiang Charioteer Pharmaceutical Co., Ltd. in Taizhou, Zhejiang (FEI 3002808516) after an inspection that ran Jan 15 – Jan 18, 2018. The investigator was Michael A. Charles. 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
Investigations are not always…
- 02
Validation does not always include full establishment of process parameters. a) Regarding cleaning validation, written procedures…
This inspection in context
Michael A. Charles
29 documents · 2013–2024
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Colorado.
The firmZhejiang Charioteer Pharmaceutical Co., Ltd. history
The site's inspection history, in date order.
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See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Zhejiang Charioteer 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 Zhejiang Charioteer Pharmaceutical Co., Ltd.?
Michael A. Charles is named on this Form 483, for the inspection of Jan 15 – Jan 18, 2018. Each investigator has a profile showing what they cite most.
When was Zhejiang Charioteer Pharmaceutical Co., Ltd. inspected by FDA?
The inspection ran Jan 15 – Jan 18, 2018, and the Form 483 is dated January 18, 2018.
How do I get the full Form 483 for Zhejiang Charioteer 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.