Changzhou SPL Company, Ltd.
Form 483 issued February 28, 2008 · Wujin, Changzhou City, Maryland
- Inspection
- Feb 20 – Feb 26, 2008
- Investigators
- Regina Brown· Zi-Qiang Gu
- Observations
- 11
- Pages
- 3
In short: On February 28, 2008, FDA issued a Form 483 with 11 observations to Changzhou SPL Company, Ltd. in Wujin, Changzhou City, Maryland 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; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
Observations span 4 systems, led by production.
Most cited: 21 CFR 211.100 (2×)
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 no critical processing steps identified for the Heparin Sodium USP process, and the…
- 02
There has been no impurity profile established for Heparin Sodium USP and no evaluation for degradants…
- 03
The manufacturing instructions for Heparin Sodium USP are incomplete in that they do not include a…
- 04
There has been no test 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 materials. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). 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 28, 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.