Qilu Pharmaceutical (Hainan) Co., Ltd.
FDA inspection history in Haikou, China, 2019
- 1
- Form 483
Every document, by year
- Form 483
2019: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2019One Form 483, at Haikou, China.
Cited most
Across all Qilu Pharmaceutical (Hainan) Co. observations on file
- 21 CFR 211.110Sampling and testing of in-process materials and drug products2
- 21 CFR 211.113Control of microbiological contamination1
- 21 CFR 211.192Production record review1
- 21 CFR 211.68Automatic, mechanical, and electronic equipment1
The complete Qilu Pharmaceutical (Hainan) Co. file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Haikou, China
One Form 483 · 2019 · 5 observations
Latest: Form 483, Nov 6, 2019 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2019-11-06 | 483 Form 483 | Haikou, China | 5 | $99 |
Investigators on these documents
FEI number 3008250362 · most recent document Nov 6, 2019
About Qilu Pharmaceutical (Hainan) Co., Ltd.
How many FDA Form 483s has Qilu Pharmaceutical (Hainan) Co., Ltd. received?
FDA Intel has 1 Form 483 on file for Qilu Pharmaceutical (Hainan) Co., Ltd.; the most recent is dated Nov 6, 2019.
When was Qilu Pharmaceutical (Hainan) Co., Ltd. last inspected by FDA?
The most recent FDA inspection document on file for Qilu Pharmaceutical (Hainan) Co., Ltd. is a Form 483 dated Nov 6, 2019, for the site in Haikou, China.
What did FDA cite at Qilu Pharmaceutical (Hainan) Co., Ltd.?
The regulations cited most in the observations on file for Qilu Pharmaceutical (Hainan) Co., Ltd. are 21 CFR 211.110 (Sampling and testing of in-process materials and drug products), 2 times; 21 CFR 211.113 (Control of microbiological contamination), 1 time; 21 CFR 211.192 (Production record review), 1 time.