SUMITOMO OSAKA CEMENT CO., LTD.
Form 483 issued October 27, 2023 · KAIZUKA, Japan
- Observations
- 5
- Pages
- 6
- FEI number
- 3003943727
In short: On October 27, 2023, FDA issued a Form 483 with 5 observations to SUMITOMO OSAKA CEMENT CO., LTD. in KAIZUKA, OSAKA (FEI 3003943727). Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Facilities & equipment and quality system account for 4 of 5 observations.
Most cited: 21 CFR 211.192 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Cleaning Validation Program is…
- 02
Out of Specification investigation (OOS) is deficient and further no CAPA is…
- 03
Reports of analysis from component suppliers are accepted without establishing the reliability of the supplier's analyses…
- 04
The roles and responsibilities of the quality unit…
This inspection in context
Questions about this 483
What did FDA find at SUMITOMO OSAKA CEMENT CO., LTD.?
FDA listed 5 observations on this Form 483, mostly about facilities & equipment, quality system and materials. 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 SUMITOMO OSAKA CEMENT CO., LTD. inspected by FDA?
This Form 483 is dated October 27, 2023.
How do I get the full Form 483 for SUMITOMO OSAKA CEMENT CO., LTD.?
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