FDA Inspection
CELESTE INDUSTRIES CORPORATIONCELESTE INDUSTRIES CORPORATION – FDA Inspection, Feb 28, 2025
Record Details
This FDA Inspection record concerns CELESTE INDUSTRIES CORPORATION, with an inspection on February 28, 2025, issued by the Baltimore District Office, covering human drugs.
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ID · 8ad5e0d7-2dea-4f82-8e9f-2112b00beec0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1262831
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
7- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.84(d)(1)Component identity verification
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.194(a)(8)Second person sign off
- 21 CFR 211.165(e)Test methods
- 21 CFR 211.160(a)Lab controls established, including changes
- 21 CFR 211.180(e)(1)Review of representative number of batches
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Other FDA inspections of CELESTE INDUSTRIES CORPORATION
1| Date | Classification | Office | Project area |
|---|---|---|---|
| May 17, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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