Sekisui Medical Co., Ltd. 4-115, Matsuo
Form 483 issued June 17, 2016 · Iwate, Japan
- Inspection
- Jun 13 – Jun 17, 2016
- Investigator
- Justin A. Boyd
- Observations
- 1
- Pages
- 7
- FEI number
- 3002806840
In short: On June 17, 2016, FDA issued a Form 483 with 1 observation to Sekisui Medical Co., Ltd. 4-115, Matsuo in Iwate, Japan (FEI 3002806840) after an inspection that ran Jun 13 – Jun 17, 2016. The investigator was Justin A. Boyd. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.194 (laboratory records).
At a glance
1 of 1 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.194 (1×) · 211.68 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Failure to maintain and…
This inspection in context
Justin A. Boyd
61 documents · 2010–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in India.
The firmSekisui Medical Co., Ltd. 4-115, Matsuo history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.194
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Sekisui Medical Co., Ltd. 4-115, Matsuo?
FDA listed 1 observation on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.194 (laboratory records). The opening words of each observation are shown on this page.
Who inspected Sekisui Medical Co., Ltd. 4-115, Matsuo?
Justin A. Boyd is named on this Form 483, for the inspection of Jun 13 – Jun 17, 2016. Each investigator has a profile showing what they cite most.
When was Sekisui Medical Co., Ltd. 4-115, Matsuo inspected by FDA?
The inspection ran Jun 13 – Jun 17, 2016, and the Form 483 is dated June 17, 2016.
How do I get the full Form 483 for Sekisui Medical Co., Ltd. 4-115, Matsuo?
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.