Qilu Pharmaceutical Co., Ltd.(High Tech Zone Site)
FDA inspection history in Jinan, China, 2013 to 2025
- 4
- Form 483s
Every document, by year
- Form 483
2013: one Form 483; 2015: one Form 483; 2017: one Form 483; 2025: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2013–17Three Form 483s, at Jinan, China.
- 2013The longest 483 on file: 12 observations over 10 pages at Jinan, China.
- 2025One Form 483, at Jinan, China.
Cited most
Across all Qilu Pharmaceutical Co., Ltd.(High Tech Zone Site) observations on file
- 21 CFR 211.113Control of microbiological contamination5
- 21 CFR 211.160General requirements4
- 21 CFR 211.188Batch production and control records3
- 21 CFR 211.192Production record review2
- 21 CFR 211.194Laboratory records2
The complete Qilu Pharmaceutical Co., Ltd.(High Tech Zone Site) file.
All 4 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
Jinan, China
Four Form 483s · 2013 to 2025 · 29 observations
Latest: Form 483, Jan 14, 2025 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-01-14 | 483 Form 483 | Jinan, China | 10 | $99 |
| 2017-09-20 | 483 Form 483 | Jinan, China | 1 | $99 |
| 2015-05-19 | 483 Form 483 | Jinan, China | 6 | $99 |
| 2013-07-18 | 483 Form 483 | Jinan, China | 12 | $99 |
Investigators on these documents
Justin A. Boyd (2)Felix Maldonado (1)Jeffrey P. Raimondi (1)Santos E. Camara (1)Zachary A. Bogorad (1)
FEI number 3003802432 · most recent document Jan 14, 2025
About Qilu Pharmaceutical Co., Ltd.(High Tech Zone Site)
How many FDA Form 483s has Qilu Pharmaceutical Co., Ltd.(High Tech Zone Site) received?
FDA Intel has 4 Form 483s on file for Qilu Pharmaceutical Co., Ltd.(High Tech Zone Site); the most recent is dated Jan 14, 2025.
When was Qilu Pharmaceutical Co., Ltd.(High Tech Zone Site) last inspected by FDA?
The most recent FDA inspection document on file for Qilu Pharmaceutical Co., Ltd.(High Tech Zone Site) is a Form 483 dated Jan 14, 2025, for the site in Jinan, China.
What did FDA cite at Qilu Pharmaceutical Co., Ltd.(High Tech Zone Site)?
The regulations cited most in the observations on file for Qilu Pharmaceutical Co., Ltd.(High Tech Zone Site) are 21 CFR 211.113 (Control of microbiological contamination), 5 times; 21 CFR 211.160 (General requirements), 4 times; 21 CFR 211.188 (Batch production and control records), 3 times.