Tianjin Asymchem Pharmaceuticals Co., Ltd.
Form 483 issued December 6, 2019 · Tianjin, China
- Inspection
- Dec 2 – Dec 6, 2019
- Investigators
- Marijo B. Kambere· Wenzheng Zhang
- Observations
- 5
- Pages
- 6
- FEI number
- 3013090624
In short: On December 6, 2019, FDA issued a Form 483 with 5 observations to Tianjin Asymchem Pharmaceuticals Co., Ltd. in Tianjin, Tianjin (FEI 3013090624) after an inspection that ran Dec 2 – Dec 6, 2019. The investigators were Marijo B. Kambere and Wenzheng Zhang. Most observations concern laboratory controls and quality system.
At a glance
Laboratory controls and quality system account for 3 of 5 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Laboratory controls fail to include the establishment of scientifically sound and appropriate analytical methods, specifications, and…
- 02
Your firm lacks scientifically sound procedures for…
- 03
The responsibilities of Quality Unit…
- 04
Change control is…
This inspection in context
Marijo B. Kambere
11 documents · 2015–2021
Cites 211.100 (written procedures; deviations) 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 211.160
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 5 observations on this Form 483, mostly about laboratory controls, quality system and production. The opening words of each observation are shown on this page.
Who inspected Tianjin Asymchem Pharmaceuticals Co., Ltd.?
Marijo B. Kambere and Wenzheng Zhang are named on this Form 483, for the inspection of Dec 2 – Dec 6, 2019. Each investigator has a profile showing what they cite most.
When was Tianjin Asymchem Pharmaceuticals Co., Ltd. inspected by FDA?
The inspection ran Dec 2 – Dec 6, 2019, and the Form 483 is dated December 6, 2019.
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.