FDA Inspection
Hyland's Consumer Health Inc.Hyland's Consumer Health Inc. – FDA Inspection, Jun 22, 2009
Record Details
This FDA Inspection record concerns Hyland's Consumer Health Inc., with an inspection on June 22, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- June 22, 2009
- Product Type
- Drugs
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ID · dc05fb9c-1ffb-4a7a-a08c-4a316cc06932
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 591208
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
4- 21 CFR 314.80(b)Failure to review ADE information
- 21 CFR 314.81(b)(2)Timely submission
- 21 CFR 211.180(e)(1)Review of representative number of batches
- 21 CFR 314.80(b)Failure to develop written procedures
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Other FDA inspections of Hyland's Consumer Health Inc.
8| Date | Classification | Office | Project area |
|---|---|---|---|
| April 22, 2026 | Not classified | Los Angeles District Office | Drug Quality Assurance |
| November 29, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 3, 2018 | Not classified | Los Angeles District Office | Drug Quality Assurance |
| October 27, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 10, 2014 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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