Sato Pharmaceutical Co., Ltd
Form 483 issued October 25, 2019 · Hachioji, Japan
- Inspection
- Oct 17 – Oct 25, 2019
- Investigator
- Jason R. Caballero
- Observations
- 8
- Pages
- 6
- FEI number
- 3004055563
In short: On October 25, 2019, FDA issued a Form 483 with 8 observations to Sato Pharmaceutical Co., Ltd in Hachioji, Tokyo (FEI 3004055563) after an inspection that ran Oct 17 – Oct 25, 2019. The investigator was Jason R. Caballero. Most observations concern facilities & equipment and laboratory controls.
At a glance
Facilities & equipment and laboratory controls account for 5 of 8 observations.
What FDA observed
Preview: the opening words of each observation- 01
Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination that would…
- 02
Routine inspection and checking of automatic and electronic equipment is not performed according to a written…
- 03
Established standards and laboratory control mechanisms are not followed. Electronic records are used, but they do…
- 04
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
This inspection in context
Jason R. Caballero
26 documents · 2014–2020
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Texas.
The firmSato Pharmaceutical Co., Ltd history
All 5 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.67(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Sato Pharmaceutical Co., Ltd?
FDA listed 8 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 Sato Pharmaceutical Co., Ltd?
Jason R. Caballero is named on this Form 483, for the inspection of Oct 17 – Oct 25, 2019. Each investigator has a profile showing what they cite most.
When was Sato Pharmaceutical Co., Ltd inspected by FDA?
The inspection ran Oct 17 – Oct 25, 2019, and the Form 483 is dated October 25, 2019.
How do I get the full Form 483 for Sato 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.