Zhejiang Tianyu Pharmaceutical Co., Ltd.
Form 483 issued March 4, 2022 · Taizhou City, China
- Inspection
- Feb 28 – Mar 4, 2022
- Investigators
- Dennis Cantellops· Laimimer Kuilan-Torres· Marcus A. Ray
- Observations
- 3
- Pages
- 3
- FEI number
- 3010972581
In short: On March 4, 2022, FDA issued a Form 483 with 3 observations to Zhejiang Tianyu Pharmaceutical Co., Ltd. in Taizhou City, Zhej iang (FEI 3010972581) after an inspection that ran Feb 28 – Mar 4, 2022. The investigators were Dennis Cantellops, Laimimer Kuilan-Torres and Marcus A. Ray. 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 3 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
Your firm failed to extend investigations to other batches that may have been associated with a…
- 02
There is a failure to thoroughly review any unexplained discrepancy or any of its components to…
- 03
Equipment and utensils are not cleaned or maintained at appropriate intervals to prevent contamination that would…
This inspection in context
Dennis Cantellops
10 documents · 2015–2024
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in India.
The firmZhejiang Tianyu Pharmaceutical Co., Ltd. history
All 6 documents on file for this site, in date order, with what was cited at each inspection.
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 Zhejiang Tianyu Pharmaceutical Co., Ltd.?
FDA listed 3 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 Zhejiang Tianyu Pharmaceutical Co., Ltd.?
Dennis Cantellops, Laimimer Kuilan-Torres and Marcus A. Ray are named on this Form 483, for the inspection of Feb 28 – Mar 4, 2022. Each investigator has a profile showing what they cite most.
When was Zhejiang Tianyu Pharmaceutical Co., Ltd. inspected by FDA?
The inspection ran Feb 28 – Mar 4, 2022, and the Form 483 is dated March 4, 2022.
How do I get the full Form 483 for Zhejiang Tianyu Pharmaceutical Co., Ltd.?
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