Regis Technologies Inc.
Form 483 issued November 16, 2022 · Morton Grove, Illinois
- Inspection
- Nov 2 – Nov 16, 2022
- Observations
- 2
- Pages
- 4
- FEI number
- 1416120
In short: On November 16, 2022, FDA issued a Form 483 with 2 observations to Regis Technologies Inc. in Morton Grove, Illinois (FEI 1416120) after an inspection that ran Nov 2 – Nov 16, 2022. Most observations concern quality system and materials; the most-cited regulation is 21 CFR 211.89 (rejected components, drug product containers, and closures).
At a glance
Quality system and materials account for 2 of 2 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
1) Your Quality Unit failed to ensure all production deviations are reported and evaluated, and that…
- 02
2) Your Quality Unit failed to identify the rejected materials that were failed to…
This inspection in context
Questions about this 483
What did FDA find at Regis Technologies Inc.?
FDA listed 2 observations on this Form 483, mostly about quality system and materials. 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.
When was Regis Technologies Inc. inspected by FDA?
The inspection ran Nov 2 – Nov 16, 2022, and the Form 483 is dated November 16, 2022.
How do I get the full Form 483 for Regis Technologies Inc.?
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