Tianjin Tianyao Pharmaceuticals Co., Ltd.
Form 483 issued September 2, 2016 · Tianjin, China
- Inspection
- Aug 29 – Sep 2, 2016
- Investigator
- Sandra A. Hughes
- Observations
- 6
- Pages
- 3
- FEI number
- 3008256667
In short: On September 2, 2016, FDA issued a Form 483 with 6 observations to Tianjin Tianyao Pharmaceuticals Co., Ltd. in Tianjin, China (FEI 3008256667) after an inspection that ran Aug 29 – Sep 2, 2016. The investigator was Sandra A. Hughes. Most observations concern laboratory controls and production.
At a glance
Laboratory controls and production account for 4 of 6 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Failure to maintain complete data derived from all testing pertaining to data retention and discrepancies in…
- 02
Potable water used in the manufacturing of a non-sterile API intended to be suitable for use…
- 03
Test procedures used in stability testing…
- 04
The following discrepancies were noted during the review of the cleaning documentation associated with…
This inspection in context
Sandra A. Hughes
23 documents · 2009–2019
Cites 211.67 (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in Wisconsin.
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 211.194
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 6 observations on this Form 483, mostly about laboratory controls, production and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Tianjin Tianyao Pharmaceuticals Co., Ltd.?
Sandra A. Hughes is named on this Form 483, for the inspection of Aug 29 – Sep 2, 2016. Each investigator has a profile showing what they cite most.
When was Tianjin Tianyao Pharmaceuticals Co., Ltd. inspected by FDA?
The inspection ran Aug 29 – Sep 2, 2016, and the Form 483 is dated September 2, 2016.
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.