Tosoh Bioscience Inc
Form 483 issued June 28, 2016 · Grove City, Ohio
- Inspection
- May 16 – Jun 28, 2016
- Investigator
- Rosanna M. Goodrich
- Observations
- 6
- Pages
- 9
- FEI number
- 3005529799
In short: On June 28, 2016, FDA issued a Form 483 with 6 observations to Tosoh Bioscience Inc in Grove City, Ohio (FEI 3005529799) after an inspection that ran May 16 – Jun 28, 2016. The investigator was Rosanna M. Goodrich. Most observations concern production & process controls and cAPA.
At a glance
Production & process controls and capa account for 5 of 6 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures for corrective and preventive action have…
- 02
Complaints involving the possible failure of a device and labeling to meet any of its specifications…
- 03
A process whose results cannot be fully verified by subsequent inspection and test has not been…
- 04
Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements…
This inspection in context
Rosanna M. Goodrich
13 documents · 2015–2025
Cites 820.100(a) (corrective and preventive action) more than any other section. Most of their documents are for sites in Ohio.
The firmTosoh Bioscience Inc history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Tosoh Bioscience Inc?
FDA listed 6 observations on this Form 483, mostly about production & process controls, cAPA and management controls. The opening words of each observation are shown on this page.
Who inspected Tosoh Bioscience Inc?
Rosanna M. Goodrich is named on this Form 483, for the inspection of May 16 – Jun 28, 2016. Each investigator has a profile showing what they cite most.
When was Tosoh Bioscience Inc inspected by FDA?
The inspection ran May 16 – Jun 28, 2016, and the Form 483 is dated June 28, 2016.
How do I get the full Form 483 for Tosoh Bioscience Inc?
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.