FDA Inspection
Professional Disposables International, Inc.Professional Disposables International, Inc. – FDA Inspection, Sep 11, 2024
Record Details
This FDA Inspection record concerns Professional Disposables International, Inc., with an inspection on September 11, 2024, issued by the New York District Office, covering human drugs.
- Inspection Date
- September 11, 2024
- Product Type
- Human Drugs
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ID · e0efdb0c-85a6-417a-8591-1c8eb8defbcf
Inspection Facts
- Inspection number
- 1242119
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 211.180(e)(2)Items to cover on annual reviews
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.84(d)(1)Component identity verification
- 21 CFR 211.84(d)(2)Establish reliability of supplier's C of A
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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 | |
| 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 |
| December 1, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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