Zhejiang Tianyu Pharmaceutical Co., Ltd.
Form 483 issued April 12, 2019 · Taizhou, China
- Inspection
- Apr 8 – Apr 12, 2019
- Investigator
- Laurimer Kuilan-Torres
- Observations
- 5
- Pages
- 3
- FEI number
- 3010972581
In short: On April 12, 2019, FDA issued a Form 483 with 5 observations to Zhejiang Tianyu Pharmaceutical Co., Ltd. in Taizhou, Zhejiang (FEI 3010972581) after an inspection that ran Apr 8 – Apr 12, 2019. The investigator was Laurimer Kuilan-Torres. Most observations concern quality system and facilities & equipment.
At a glance
Quality system and facilities & equipment account for 4 of 5 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written records are not always made of investigations into the failure of a batch or any…
- 02
The responsibilities between your firm and the contract laboratory have…
- 03
The validation of your firm's cleaning process for manufacturing equipment is deficient in that the cleaning…
- 04
The process validation for API under…
This inspection in context
Laurimer Kuilan-Torres
16 documents · 2015–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Puerto Rico.
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 5 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 Tianyu Pharmaceutical Co., Ltd.?
Laurimer Kuilan-Torres is named on this Form 483, for the inspection of Apr 8 – Apr 12, 2019. Each investigator has a profile showing what they cite most.
When was Zhejiang Tianyu Pharmaceutical Co., Ltd. inspected by FDA?
The inspection ran Apr 8 – Apr 12, 2019, and the Form 483 is dated April 12, 2019.
How do I get the full Form 483 for Zhejiang Tianyu 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.