Zhejiang Tianyu Pharmaceutical Co., Ltd.
Form 483 issued November 29, 2024 · Taizhou, China
- Inspection
- Nov 21 – Nov 29, 2024
- Investigators
- Alan A. Rivera· Pratik S. Upadhyay
- Observations
- 2
- Pages
- 4
- FEI number
- 3010972581
In short: On November 29, 2024, FDA issued a Form 483 with 2 observations to Zhejiang Tianyu Pharmaceutical Co., Ltd. in Taizhou, Zhejiang (FEI 3010972581) after an inspection that ran Nov 21 – Nov 29, 2024. The investigators were Alan A. Rivera and Pratik S. Upadhyay. Most observations concern laboratory controls and facilities & equipment; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Laboratory controls and facilities & equipment account for 2 of 2 observations.
Most cited: 21 CFR 211.160 (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
Failure to establish an impurity profile for…
- 02
Failure to clean equipment at appropriate intervals to prevent build-up and carryover of contaminants and degradants…
This inspection in context
Alan A. Rivera
16 documents · 2022–2026
Cites 211.160 (general requirements) 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 211.160
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 2 observations on this Form 483, mostly about laboratory controls and facilities & equipment. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Zhejiang Tianyu Pharmaceutical Co., Ltd.?
Alan A. Rivera and Pratik S. Upadhyay are named on this Form 483, for the inspection of Nov 21 – Nov 29, 2024. Each investigator has a profile showing what they cite most.
When was Zhejiang Tianyu Pharmaceutical Co., Ltd. inspected by FDA?
The inspection ran Nov 21 – Nov 29, 2024, and the Form 483 is dated November 29, 2024.
How do I get the full Form 483 for Zhejiang Tianyu Pharmaceutical Co., Ltd.?
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