Qilu Pharmaceutical Co., Ltd.(High Tech Zone Site)
Form 483 issued July 18, 2013 · Jinan, China
- Inspection
- Jul 8 – Jul 18, 2013
- Investigators
- Felix Maldonado· Justin A. Boyd
- Observations
- 12
- Pages
- 10
- FEI number
- 3003802432
In short: On July 18, 2013, FDA issued a Form 483 with 12 observations to Qilu Pharmaceutical Co., Ltd.(High Tech Zone Site) in Jinan, Shandong (FEI 3003802432) after an inspection that ran Jul 8 – Jul 18, 2013. The investigators were Felix Maldonado and Justin A. Boyd. Most observations concern laboratory controls and production; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Laboratory controls and production account for 6 of 10 observations.
Most cited: 21 CFR 211.160 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your firm failed to ensure that laboratory records included complete data derived from all tests necessary…
- 03
Observation 3: scanned text, readable in the full document.
- 04
A system for cleaning and disinfecting the aseptic filling room and equipment was not established…
- 05
For the process of performing a 100% visual inspection of finished vials: . woo. : O®…
This inspection in context
Felix Maldonado
6 documents · 2009–2019
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in New York.
The firmQilu Pharmaceutical Co., Ltd.(High Tech Zone Site) history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Qilu Pharmaceutical Co., Ltd.(High Tech Zone Site)?
FDA listed 12 observations on this Form 483, mostly about laboratory controls, production and facilities & equipment. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Qilu Pharmaceutical Co., Ltd.(High Tech Zone Site)?
Felix Maldonado and Justin A. Boyd are named on this Form 483, for the inspection of Jul 8 – Jul 18, 2013. Each investigator has a profile showing what they cite most.
When was Qilu Pharmaceutical Co., Ltd.(High Tech Zone Site) inspected by FDA?
The inspection ran Jul 8 – Jul 18, 2013, and the Form 483 is dated July 18, 2013.
How do I get the full Form 483 for Qilu Pharmaceutical Co., Ltd.(High Tech Zone Site)?
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.