Qilu Pharmaceutical Co., Ltd.(High Tech Zone Site)
Form 483 issued May 19, 2015 · Jinan, China
- Inspection
- May 11 – May 19, 2015
- Investigators
- Santos E. Camara· Zachary A. Bogorad
- Observations
- 6
- Pages
- 2
- FEI number
- 3003802432
In short: On May 19, 2015, FDA issued a Form 483 with 6 observations to Qilu Pharmaceutical Co., Ltd.(High Tech Zone Site) in Jinan, Shandong (FEI 3003802432) after an inspection that ran May 11 – May 19, 2015. The investigators were Santos E. Camara and Zachary A. Bogorad. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.25 (personnel qualifications).
At a glance
Production and quality system account for 5 of 6 observations.
Most cited: 21 CFR 211.188 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
100% vial inspection operator…
- 02
Non-contemporaneous completion of batch records takes place during the startup of sterile filling operations. In the…
- 03
Batch production records for «cx…
- 04
Goggles used in the Grade A and Grade B controlled filling areas are not tracked and…
This inspection in context
Santos E. Camara
33 documents · 2015–2026
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in India.
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 211.188
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 6 observations on this Form 483, mostly about production, quality system and laboratory controls. The most-cited regulation is 21 CFR 211.25 (personnel qualifications). The opening words of each observation are shown on this page.
Who inspected Qilu Pharmaceutical Co., Ltd.(High Tech Zone Site)?
Santos E. Camara and Zachary A. Bogorad are named on this Form 483, for the inspection of May 11 – May 19, 2015. 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 May 11 – May 19, 2015, and the Form 483 is dated May 19, 2015.
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.