FDA Inspection
Professional Disposables International, Inc.Professional Disposables International, Inc. – FDA Inspection, Dec 1, 2017
Record Details
This FDA Inspection record concerns Professional Disposables International, Inc., with an inspection on December 1, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · ad68ae19-bbcd-4960-ac1d-0b51678f027d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1040815
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 314.81(b)(1)(ii)Failure to meet specifications
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
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Other FDA inspections of Professional Disposables International, Inc.
12| Date | Classification | Office | Project area |
|---|---|---|---|
| March 31, 2026 | Not classified | New York District Office | Drug Quality Assurance |
| September 19, 2025 | Not classified | New York District Office | |
| September 11, 2024 | Not classified | New York District Office | Drug Quality Assurance |
| June 23, 2021 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 28, 2019 | Not classified | New York District Office | Drug Quality Assurance |
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