FDA Inspection
Topical Pharmaceuticals, Inc.Topical Pharmaceuticals, Inc. – FDA Inspection, May 7, 2026
Record Details
This FDA Inspection record concerns Topical Pharmaceuticals, Inc., with an inspection on May 7, 2026, issued by the Chicago District Office, covering human drugs.
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ID · 9a90d0fa-f872-4acf-ad47-898cb1d94013
Inspection Facts
- Inspection number
- 1315996
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
11- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.180(e)(2)Items to cover on annual reviews
- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(c)Approve or reject procedures or specs
- 21 CFR 211.42(a)Buildings of Suitable Size, Construction, Location
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.67(b)Written procedures not established/followed
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Other FDA inspections of Topical Pharmaceuticals, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| June 30, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 6, 2019 | NAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
| July 7, 2016 | NAI | Center for Drug Evaluation and Research | Unapproved and Misbranded Drugs |
| January 18, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Topical Pharmaceuticals, Inc.
- FDA Inspection 1173770 - 2022-06-30
- FDA Inspection 1094010 - 2019-06-06
- FDA Inspection 977547 - 2016-07-07
- FDA Inspection 707147 - 2011-01-18
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