Nippon Shikizai, inc.
Form 483 issued August 6, 2019 · Tsukuba, Japan
- Inspection
- Aug 1 – Aug 6, 2019
- Investigators
- Ofthis Sarah E. Rhoades· Sarah E. Rhoades
- Observations
- 3
- Pages
- 3
- FEI number
- 3012051074
In short: On August 6, 2019, FDA issued a Form 483 with 3 observations to Nippon Shikizai, inc. in Tsukuba, Ibaraki (FEI 3012051074) after an inspection that ran Aug 1 – Aug 6, 2019. The investigators were Ofthis Sarah E. Rhoades and Sarah E. Rhoades. Most observations concern facilities & equipment and quality system.
At a glance
2 of 3 observations on this 483 concern facilities & equipment.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Equipment and utensils are not cleaned at appropriate intervals to prevent contamination that would alter the…
- 02
Routine calibration and checking of equipment is not performed according to a written program designed…
- 03
The responsibilities and procedures applicable to the quality control unit…
This inspection in context
Ofthis Sarah E. Rhoades
1 document · 2019
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Japan.
The firmNippon Shikizai, inc. 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 Nippon Shikizai, inc.?
FDA listed 3 observations on this Form 483, mostly about facilities & equipment and quality system. The opening words of each observation are shown on this page.
Who inspected Nippon Shikizai, inc.?
Ofthis Sarah E. Rhoades and Sarah E. Rhoades are named on this Form 483, for the inspection of Aug 1 – Aug 6, 2019. Each investigator has a profile showing what they cite most.
When was Nippon Shikizai, inc. inspected by FDA?
The inspection ran Aug 1 – Aug 6, 2019, and the Form 483 is dated August 6, 2019.
How do I get the full Form 483 for Nippon Shikizai, 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.