FDA Inspection
Cetylite Industries, Inc.Cetylite Industries, Inc. – FDA Inspection, Apr 26, 2011
Record Details
This FDA Inspection record concerns Cetylite Industries, Inc., with an inspection on April 26, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Cetylite Industries, Inc.
- Inspection Date
- April 26, 2011
- Product Type
- Drugs
View Company Profile
ID · 5c6c18b9-a041-4ad3-bdf7-33b18e607d18
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 721355
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
5- 21 CFR 211.160(a)Deviations from laboratory control requirements
- 21 CFR 211.192Extent of discrepancy, failure investigations
- 21 CFR 211.194(d)Laboratory equipment calibration records
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.166(a)(3)Valid stability test methods
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Other FDA inspections of Cetylite Industries, Inc.
8| Date | Classification | Office | Project area |
|---|---|---|---|
| April 7, 2025 | NAI | New Jersey District Office | Postmarket Assurance: Medical Devices |
| December 9, 2024 | VAI | New Jersey District Office | Drug Quality Assurance |
| March 2, 2023 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 24, 2021 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 29, 2018 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
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