FDA Inspection
Hill Dermaceuticals, Inc.Hill Dermaceuticals, Inc. – FDA Inspection, Mar 30, 2012
Record Details
This FDA Inspection record concerns Hill Dermaceuticals, Inc., with an inspection on March 30, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Hill Dermaceuticals, Inc.
- Inspection Date
- March 30, 2012
- Product Type
- Drugs
View Company Profile
ID · 9f32097d-6592-488f-93c5-f8ec02742671
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 773876
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
11- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.194(d)Laboratory equipment calibration records
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.166(a)(4)Testing in same container - closure system
- 21 CFR 211.166(a)(3)Valid stability test methods
- 21 CFR 211.166(a)Written program not followed
- 21 CFR 211.67(b)Written procedures not established/followed
Showing 10 of 11 citations.
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Other FDA inspections of Hill Dermaceuticals, Inc.
7| Date | Classification | Office | Project area |
|---|---|---|---|
| October 14, 2025 | VAI | Florida District Office | Drug Quality Assurance |
| August 11, 2021 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 18, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 6, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 10, 2012 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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