Tianjin Tianyao Pharmaceuticals Co., Ltd.
Form 483 issued May 24, 2019 · Tianjin, China
- Investigator
- Taichun Qin
- Observations
- 4
- Pages
- 3
- FEI number
- 3008256667
In short: On May 24, 2019, FDA issued a Form 483 with 4 observations to Tianjin Tianyao Pharmaceuticals Co., Ltd. in Tianjin, China (FEI 3008256667). The investigator was Taichun Qin. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Laboratory controls and quality system account for 3 of 4 observations.
Most cited: 21 CFR 211.160 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Investigation of deviations in system suitability during the…
- 02
There is no assurance that the equipment used in the production of firm’s active pharmaceutical ingredients…
- 03
System suitability test in your established analytical procedures for starting materials does not include comparison of…
- 04
Method validation for forced degradation of active pharmaceutical ingredient does not ensure that the test is…
This inspection in context
Taichun Qin
35 documents · 2017–2025
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in California.
The firmTianjin Tianyao Pharmaceuticals 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 Tianjin Tianyao Pharmaceuticals Co., Ltd.?
FDA listed 4 observations on this Form 483, mostly about laboratory controls, quality system 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 Tianjin Tianyao Pharmaceuticals Co., Ltd.?
Taichun Qin is named on this Form 483. Each investigator has a profile showing what they cite most.
When was Tianjin Tianyao Pharmaceuticals Co., Ltd. inspected by FDA?
This Form 483 is dated May 24, 2019.
How do I get the full Form 483 for Tianjin Tianyao Pharmaceuticals 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.