Topical Pharmaceuticals Inc.

Form 483 issued June 30, 2022 · Addison, Illinois

Observations
1
Pages
3
FEI number
3005402103

In short: On June 30, 2022, FDA issued a Form 483 with 1 observation to Topical Pharmaceuticals Inc. in Addison, Illinois (FEI 3005402103). Most observations concern quality system; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).

At a glance

1 of 1 observations on this 483 concern quality system.

Quality system1

Most cited: 21 CFR 211.22 (1×) · 211.160 (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

    The responsibilities and procedures applicable to the quality control unit are not in…

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This inspection in context

Questions about this 483

What did FDA find at Topical Pharmaceuticals Inc.?

FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.

When was Topical Pharmaceuticals Inc. inspected by FDA?

This Form 483 is dated June 30, 2022.

How do I get the full Form 483 for Topical Pharmaceuticals Inc.?

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