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NIPPON FINE CHEMICAL CO.,LTD

Form 483 issued June 11, 2019 · TAKASAGO, Japan

Observations
3
Pages
2
FEI number
3001722961

In short: On June 11, 2019, FDA issued a Form 483 with 3 observations to NIPPON FINE CHEMICAL CO.,LTD in TAKASAGO, HYOGO (FEI 3001722961). Most observations concern quality system; the most-cited regulation is 21 CFR 211.192 (production record review).

At a glance

2 of 3 observations on this 483 concern quality system.

Quality system2
Other1

Most cited: 21 CFR 211.192 (1×) · 211.180 (1×)

What FDA observed

Preview: the opening words of each observation

Dashed: section inferred by FDA Intel and checked against the regulation text

  1. 01
    21 CFR 211.192

    Procedures applicable to deviations, out of specifications are not fully followed…

  2. 02
    21 CFR 211.180

    Procedures applicable to reporting Annual Drug Product…

  3. 03

    Procedures applicable to suppliers qualification for raw materials…

The full 483

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This inspection in context

The firm

NIPPON FINE CHEMICAL CO.,LTD history

All 3 documents on file for this site, in date order, with what was cited at each inspection.

Similar 483s

Other sites cited under 211.192

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Questions about this 483

What did FDA find at NIPPON FINE CHEMICAL CO.,LTD?

FDA listed 3 observations on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.

When was NIPPON FINE CHEMICAL CO.,LTD inspected by FDA?

This Form 483 is dated June 11, 2019.

How do I get the full Form 483 for NIPPON FINE CHEMICAL CO.,LTD?

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