Changzhou SPL Company, Ltd.
Form 483 issued February 26, 2008 · Wujing, Changzhou City, China
- Inspection
- Feb 20 – Feb 26, 2008
- Investigators
- Regina Brown· Zi-Qiang Gu
- Observations
- 11
- Pages
- 3
In short: On February 26, 2008, FDA issued a Form 483 with 11 observations to Changzhou SPL Company, Ltd. in Wujing, Changzhou City, China after an inspection that ran Feb 20 – Feb 26, 2008. The investigators were Regina Brown and Zi-Qiang Gu. Most observations concern production and laboratory controls.
At a glance
Production and laboratory controls 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
There have been 10 critical processing steps identified for the Heparin Sodium U spl…
- 02
There hag been no impurity profi ile established for Heparin Sodium USP and no evaluation for…
- 03
The manufacturing instructions for Heparin Sodium USF are incomplete in that they do not include a…
- 04
There has been po Lest method verification performed for the reported USP test methods, Nitrogen Determination…
This inspection in context
Regina Brown
7 documents · 2008–2013
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Michigan.
The firmChangzhou SPL Company, 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 211.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Changzhou SPL Company, Ltd.?
FDA listed 11 observations on this Form 483, mostly about production, laboratory controls and quality system. The opening words of each observation are shown on this page.
Who inspected Changzhou SPL Company, Ltd.?
Regina Brown and Zi-Qiang Gu are named on this Form 483, for the inspection of Feb 20 – Feb 26, 2008. Each investigator has a profile showing what they cite most.
When was Changzhou SPL Company, Ltd. inspected by FDA?
The inspection ran Feb 20 – Feb 26, 2008, and the Form 483 is dated February 26, 2008.
How do I get the full Form 483 for Changzhou SPL Company, 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.