FDA Inspection
Professional Disposables International, Inc.Professional Disposables International, Inc. – FDA Inspection, May 28, 2019
Record Details
This FDA Inspection record concerns Professional Disposables International, Inc., with an inspection on May 28, 2019, issued by the New York District Office, covering human drugs.
- Inspection Date
- May 28, 2019
- Product Type
- Human Drugs
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ID · ec9c0ac4-3b63-476b-84a0-a99d86ee0b78
Inspection Facts
- Inspection number
- 1090866
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
12- 21 CFR 211.142Written warehousing procedures established/followed
- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.192No written record of investigation
- 21 CFR 211.194(a)(4)Complete Test Data
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.25(b)Training records
- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
Showing 10 of 12 citations.
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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 |
| December 1, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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