Changzhou SPL Company, Ltd.
FDA inspection history across 2 sites, 2008
- 2
- Form 483s
Every document, by year
- Form 483
2008: two Form 483s.
The story so far
Built from the dates and citations on the documents themselves.
- 2008Two Form 483s, at Wujin, Changzhou City, Maryland and Wujing, Changzhou City, China.
- 2008The longest 483 on file: 11 observations over 3 pages at Wujin, Changzhou City, Maryland.
Cited most
Across all Changzhou SPL Company observations on file
- 21 CFR 211.100Written procedures; deviations3
- 21 CFR 211.166Stability testing2
- 21 CFR 211.186Master production and control records2
- 21 CFR 211.192Production record review2
- 21 CFR 211.194Laboratory records2
The complete Changzhou SPL Company file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Wujin, Changzhou City, Maryland
One Form 483 · 2008 · 11 observations
Latest: Form 483, Feb 28, 2008 →Wujing, Changzhou City, China
One Form 483 · 2008 · 11 observations
Latest: Form 483, Feb 26, 2008 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2008-02-28 | 483 Form 483 | Wujin, Changzhou City, Maryland | 11 | $99 |
| 2008-02-26 | 483 Form 483 | Wujing, Changzhou City, China | 11 | $99 |
Investigators on these documents
About Changzhou SPL Company, Ltd.
How many FDA Form 483s has Changzhou SPL Company, Ltd. received?
FDA Intel has 2 Form 483s on file for Changzhou SPL Company, Ltd.; the most recent is dated Feb 28, 2008.
When was Changzhou SPL Company, Ltd. last inspected by FDA?
The most recent FDA inspection document on file for Changzhou SPL Company, Ltd. is a Form 483 dated Feb 28, 2008, for the site in Wujin, Changzhou City, Maryland.
What did FDA cite at Changzhou SPL Company, Ltd.?
The regulations cited most in the observations on file for Changzhou SPL Company, Ltd. are 21 CFR 211.100 (Written procedures; deviations), 3 times; 21 CFR 211.166 (Stability testing), 2 times; 21 CFR 211.186 (Master production and control records), 2 times.