Tianjin Asymchem Pharmaceuticals Co., Ltd.
Form 483 issued October 19, 2021 · Tianjin, China
- Investigator
- Laurin Kailan-Tones
- Observations
- 1
- Pages
- 1
- FEI number
- 3013090624
In short: On October 19, 2021, FDA issued a Form 483 with 1 observation to Tianjin Asymchem Pharmaceuticals Co., Ltd. in Tianjin, Tianjin (FEI 3013090624). The investigator was Laurin Kailan-Tones. Most observations concern materials; the most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures).
At a glance
1 of 1 observations on this 483 concern materials.
Most cited: 21 CFR 211.84 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your firm supplier qualification for register starting material…
This inspection in context
Laurin Kailan-Tones
1 document · 2021
Cites 211.84 (testing and approval or rejection of components, drug product containers, and closures) more than any other section. Most of their documents are for sites in China.
The firmTianjin Asymchem Pharmaceuticals Co., Ltd. history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.84
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Tianjin Asymchem Pharmaceuticals Co., Ltd.?
FDA listed 1 observation on this Form 483, mostly about materials. The most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures). The opening words of each observation are shown on this page.
Who inspected Tianjin Asymchem Pharmaceuticals Co., Ltd.?
Laurin Kailan-Tones is named on this Form 483. Each investigator has a profile showing what they cite most.
When was Tianjin Asymchem Pharmaceuticals Co., Ltd. inspected by FDA?
This Form 483 is dated October 19, 2021.
How do I get the full Form 483 for Tianjin Asymchem 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.