Jianerkang Medical Co., Ltd.
FDA inspection history in Changzhou, China, 2012 to 2019
- 1
- Form 483
- 1
- Close-out
- 1
- Warning letter
Every document, by year
- Form 483
- Close-out
- Warning letter
2012: one warning letter; 2014: one close-out letter; 2019: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2012–14One warning letter and one close-out letter, at Changzhou, China.
- 2019One Form 483, at Changzhou, China.
Cited most
Across all Jianerkang Medical Co. observations on file
- 21 CFR 211.160General requirements1
- 21 CFR 211.166Stability testing1
The complete Jianerkang Medical Co. file.
All 3 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
Changzhou, China
One Form 483, one close-out letter and one warning letter · 2012 to 2019 · 2 observations
Latest: Form 483, Nov 1, 2019 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2019-11-01 | 483 Form 483 | Changzhou, China | 2 | $99 |
| 2014-11-06 | Close-out Close-out letter | Changzhou, China | — | $99 |
| 2012-07-30 | Warning letter Warning letter | Changzhou, China | — | $99 |
Investigators on these documents
FEI number 3006403682 · most recent document Nov 1, 2019
About Jianerkang Medical Co., Ltd.
How many FDA Form 483s has Jianerkang Medical Co., Ltd. received?
FDA Intel has 1 Form 483 on file for Jianerkang Medical Co., Ltd.; the most recent is dated Nov 1, 2019.
When was Jianerkang Medical Co., Ltd. last inspected by FDA?
The most recent FDA inspection document on file for Jianerkang Medical Co., Ltd. is a Form 483 dated Nov 1, 2019, for the site in Changzhou, China.
What did FDA cite at Jianerkang Medical Co., Ltd.?
The regulations cited most in the observations on file for Jianerkang Medical Co., Ltd. are 21 CFR 211.160 (General requirements), 1 time; 21 CFR 211.166 (Stability testing), 1 time.
Has Jianerkang Medical Co., Ltd. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Jianerkang Medical Co., Ltd.; the most recent is dated Jul 30, 2012.