Qilu Pharmaceutical Co., Ltd.(High Tech Zone Site)
Form 483 issued September 20, 2017 · Jinan, China
- Inspection
- Sep 13 – Sep 20, 2017
- Observations
- 1
- Pages
- 2
- FEI number
- 3003802432
In short: On September 20, 2017, FDA issued a Form 483 with 1 observation to Qilu Pharmaceutical Co., Ltd.(High Tech Zone Site) in Jinan, Shandong (FEI 3003802432) after an inspection that ran Sep 13 – Sep 20, 2017. Most observations concern production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
1 of 1 observations on this 483 concern production.
Most cited: 21 CFR 211.113 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Personnel monitoring after performing…
This inspection in context
Questions about this 483
What did FDA find at Qilu Pharmaceutical Co., Ltd.(High Tech Zone Site)?
FDA listed 1 observation on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
When was Qilu Pharmaceutical Co., Ltd.(High Tech Zone Site) inspected by FDA?
The inspection ran Sep 13 – Sep 20, 2017, and the Form 483 is dated September 20, 2017.
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.