FDA Inspection
Professional Disposables International, Inc.Professional Disposables International, Inc. – FDA Inspection, Oct 18, 2011
Record Details
This FDA Inspection record concerns Professional Disposables International, Inc., with an inspection on October 18, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- October 18, 2011
- Product Type
- Drugs
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ID · d29f7617-07c8-491a-8ea9-03b596de20cb
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 749702
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
8- 21 CFR 211.167(a)Sterility/pyrogen-free testing
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.198(a)Procedures to be written and followed
- 21 CFR 211.170(b)Reserve samples identified, representative, stored
- 21 CFR 211.160(a)Lab controls established, including changes
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.166(a)(1)Sample size - test intervals
- 21 CFR 211.67(b)Written procedures not established/followed
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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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