Zhejiang Tianyu Pharmaceutical Co., Ltd.
Form 483 issued June 12, 2015 · Taizhou, China
- Inspection
- Jun 8 – Jun 12, 2015
- Investigator
- Jose E. Melendez
- Observations
- 3
- Pages
- 2
- FEI number
- 3010972581
In short: On June 12, 2015, FDA issued a Form 483 with 3 observations to Zhejiang Tianyu Pharmaceutical Co., Ltd. in Taizhou, Zhejiang (FEI 3010972581) after an inspection that ran Jun 8 – Jun 12, 2015. The investigator was Jose E. Melendez. Most observations concern packaging & labeling; the most-cited regulation is 21 CFR 211.122 (materials examination and usage criteria).
At a glance
Observations span 1 system, led by packaging & labeling.
Most cited: 21 CFR 211.122 (1×) · 211.142 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
PRODUCTION…
- 02
PACKAGING…
- 03
Observation 3: scanned text, readable in the full document.
This inspection in context
Jose E. Melendez
44 documents · 2001–2026
Cites 211.192 (production record review) 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 211.122
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 packaging & labeling. The most-cited regulation is 21 CFR 211.122 (materials examination and usage criteria). The opening words of each observation are shown on this page.
Who inspected Zhejiang Tianyu Pharmaceutical Co., Ltd.?
Jose E. Melendez is named on this Form 483, for the inspection of Jun 8 – Jun 12, 2015. Each investigator has a profile showing what they cite most.
When was Zhejiang Tianyu Pharmaceutical Co., Ltd. inspected by FDA?
The inspection ran Jun 8 – Jun 12, 2015, and the Form 483 is dated June 12, 2015.
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.