FDA Inspection
Hill Dermaceuticals, Inc.Hill Dermaceuticals, Inc. – FDA Inspection, May 18, 2018
Record Details
This FDA Inspection record concerns Hill Dermaceuticals, Inc., with an inspection on May 18, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · c7f3f4b3-dbce-4602-9d4c-25b5112af58c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1053606
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 211.58Buildings not maintained in good state of repair
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.194(d)Laboratory equipment calibration records
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.166(a)(3)Valid stability test methods
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Other FDA inspections of Hill Dermaceuticals, Inc.
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|---|---|---|---|
| October 14, 2025 | VAI | Florida District Office | Drug Quality Assurance |
| August 11, 2021 | 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 |
| March 30, 2012 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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