Nippon Sanso Matheson, Inc.
Form 483 issued April 5, 2017 · Bangor, Maine
- Inspection
- Apr 3 – Apr 5, 2017
- Investigator
- Sean R. Marcsisin
- Observations
- 2
- Pages
- 3
- FEI number
- 1221345
In short: On April 5, 2017, FDA issued a Form 483 with 2 observations to Nippon Sanso Matheson, Inc. in Bangor, Maine (FEI 1221345) after an inspection that ran Apr 3 – Apr 5, 2017. The investigator was Sean R. Marcsisin. Most observations concern materials and quality system; the most-cited regulation is 21 CFR 211.89 (rejected components, drug product containers, and closures).
At a glance
Materials and quality system account for 2 of 2 observations.
Most cited: 21 CFR 211.89 (1×) · 211.22(d) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Rejected drug product containers are not controlled under a quarantine system designed to prevent their use…
- 02
The responsibilities and procedures applicable to the quality control unit…
This inspection in context
Sean R. Marcsisin
22 documents · 2016–2025
Cites 211.67 (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in Massachusetts.
The firmNippon Sanso Matheson, Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.89
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Nippon Sanso Matheson, Inc.?
FDA listed 2 observations on this Form 483, mostly about materials and quality system. The most-cited regulation is 21 CFR 211.89 (rejected components, drug product containers, and closures). The opening words of each observation are shown on this page.
Who inspected Nippon Sanso Matheson, Inc.?
Sean R. Marcsisin is named on this Form 483, for the inspection of Apr 3 – Apr 5, 2017. Each investigator has a profile showing what they cite most.
When was Nippon Sanso Matheson, Inc. inspected by FDA?
The inspection ran Apr 3 – Apr 5, 2017, and the Form 483 is dated April 5, 2017.
How do I get the full Form 483 for Nippon Sanso Matheson, 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.