Linhai Tianyu Pharmaceutical Co., Ltd.
Form 483 issued April 19, 2019 · Taizhou, China
- Inspection
- Apr 15 – Apr 19, 2019
- Investigators
- Joe D. Hustedt· Joel D. Hustedt
- Observations
- 10
- Pages
- 6
- FEI number
- 3013345425
In short: On April 19, 2019, FDA issued a Form 483 with 10 observations to Linhai Tianyu Pharmaceutical Co., Ltd. in Taizhou, Zhejiang (FEI 3013345425) after an inspection that ran Apr 15 – Apr 19, 2019. The investigators were Joe D. Hustedt and Joel D. Hustedt. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Observations span 4 systems, led by facilities & equipment.
Most cited: 21 CFR 211.160 (2×) · 211.67 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your firm does not evaluate existing impurity profiles to…
- 02
Observation 2: scanned text, readable in the full document.
- 03
Observation 3: scanned text, readable in the full document.
- 04
Your firm’s cleaning validation for he: 16 and 7 used in…
This inspection in context
Joe D. Hustedt
1 document · 2019
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in China.
The firmLinhai Tianyu Pharmaceutical Co., Ltd. history
All 2 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 Linhai Tianyu Pharmaceutical Co., Ltd.?
FDA listed 10 observations on this Form 483, mostly about facilities & equipment, quality system and laboratory controls. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected Linhai Tianyu Pharmaceutical Co., Ltd.?
Joe D. Hustedt and Joel D. Hustedt are named on this Form 483, for the inspection of Apr 15 – Apr 19, 2019. Each investigator has a profile showing what they cite most.
When was Linhai Tianyu Pharmaceutical Co., Ltd. inspected by FDA?
The inspection ran Apr 15 – Apr 19, 2019, and the Form 483 is dated April 19, 2019.
How do I get the full Form 483 for Linhai 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.