Ono Pharmaceutical Co., Ltd.
Form 483 issued December 21, 2018 · FUJINOMIYA, Japan
- Inspection
- Dec 17 – Dec 21, 2018
- Investigator
- Dennis Cantellops
- Observations
- 3
- Pages
- 2
- FEI number
- 3002807805
In short: On December 21, 2018, FDA issued a Form 483 with 3 observations to Ono Pharmaceutical Co., Ltd. in FUJINOMIYA, SHIZUOKA (FEI 3002807805) after an inspection that ran Dec 17 – Dec 21, 2018. The investigator was Dennis Cantellops. Most observations concern facilities & equipment and laboratory controls.
At a glance
Facilities & equipment and laboratory controls account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
(Material System) Procedures for the cleaning and maintenance of equipment are deficient regarding assignment of responsibility…
- 02
(Laboratory Control System) Laboratory controls do not include the establishment of scientifically sound and appropriate test…
- 03
( Quality System) The responsibilities and procedures applicable to the quality control unit…
This inspection in context
Dennis Cantellops
10 documents · 2015–2024
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in India.
The firmOno Pharmaceutical Co., Ltd. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Ono Pharmaceutical Co., Ltd.?
FDA listed 3 observations on this Form 483, mostly about facilities & equipment, laboratory controls and quality system. The opening words of each observation are shown on this page.
Who inspected Ono Pharmaceutical Co., Ltd.?
Dennis Cantellops is named on this Form 483, for the inspection of Dec 17 – Dec 21, 2018. Each investigator has a profile showing what they cite most.
When was Ono Pharmaceutical Co., Ltd. inspected by FDA?
The inspection ran Dec 17 – Dec 21, 2018, and the Form 483 is dated December 21, 2018.
How do I get the full Form 483 for Ono Pharmaceutical Co., Ltd.?
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.