Zhejiang Ausun Pharmaceutical Co., Ltd.
Form 483 issued October 31, 2014 · Taizhou, China
- Inspection
- Oct 27 – Oct 31, 2014
- Investigator
- Michael R. Goga
- Observations
- 3
- Pages
- 2
- FEI number
- 3009065969
In short: On October 31, 2014, FDA issued a Form 483 with 3 observations to Zhejiang Ausun Pharmaceutical Co., Ltd. in Taizhou, Zhejiang (FEI 3009065969) after an inspection that ran Oct 27 – Oct 31, 2014. The investigator was Michael R. Goga.
What FDA observed
Preview: the opening words of each observation- 01
The critical process parameter (CPP) results reported in Drug Master File No.” Version 3.3, do not…
- 02
Error corrections to controlled documents are not always completed in accordance with SOP AM-0007, Filling, Review…
- 03
Calibrated clocks are not posted in all areas of where time entries are made into the…
This inspection in context
Questions about this 483
What did FDA find at Zhejiang Ausun Pharmaceutical Co., Ltd.?
FDA listed 3 observations on this Form 483. The opening words of each observation are shown on this page.
Who inspected Zhejiang Ausun Pharmaceutical Co., Ltd.?
Michael R. Goga is named on this Form 483, for the inspection of Oct 27 – Oct 31, 2014. Each investigator has a profile showing what they cite most.
When was Zhejiang Ausun Pharmaceutical Co., Ltd. inspected by FDA?
The inspection ran Oct 27 – Oct 31, 2014, and the Form 483 is dated October 31, 2014.
How do I get the full Form 483 for Zhejiang Ausun 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.