Nippon Sanso Matheson, Inc.
Form 483 issued December 9, 2022 · Dallas, Texas
- Inspection
- Dec 6 – Dec 9, 2022
- Investigators
- Kevin T. Nguyen· Margaret M. Annes· Shanna N. Purdy
- Observations
- 1
- Pages
- 2
- FEI number
- 1627208
In short: On December 9, 2022, FDA issued a Form 483 with 1 observation to Nippon Sanso Matheson, Inc. in Dallas, Texas (FEI 1627208) after an inspection that ran Dec 6 – Dec 9, 2022. The investigators were Kevin T. Nguyen, Margaret M. Annes and Shanna N. Purdy. Most observations concern quality system; the most-cited regulation is 21 CFR 211.180 (general requirements).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.180(e) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Records are not maintained so that data therein can be reviewed at least annually to evaluate…
This inspection in context
Kevin T. Nguyen
5 documents · 2022–2024
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in Texas.
The firmNippon Sanso Matheson, Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.180(e)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Nippon Sanso Matheson, Inc.?
FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.180 (general requirements). The opening words of each observation are shown on this page.
Who inspected Nippon Sanso Matheson, Inc.?
Kevin T. Nguyen, Margaret M. Annes and Shanna N. Purdy are named on this Form 483, for the inspection of Dec 6 – Dec 9, 2022. Each investigator has a profile showing what they cite most.
When was Nippon Sanso Matheson, Inc. inspected by FDA?
The inspection ran Dec 6 – Dec 9, 2022, and the Form 483 is dated December 9, 2022.
How do I get the full Form 483 for Nippon Sanso Matheson, Inc.?
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