FDA Inspection
Pharmacy Resources IncorporatedPharmacy Resources Incorporated – FDA Inspection, May 23, 2017
Record Details
This FDA Inspection record concerns Pharmacy Resources Incorporated, with an inspection on May 23, 2017, issued by the Denver District Office, covering human drugs.
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ID · ed09b412-3d37-4327-8bc5-7a0b74e6740e
Inspection Facts
- Inspection number
- 1016849
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.28(a)Protective Apparel Not Worn
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.42(c)(10)(v)Cleaning System
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
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Other FDA inspections of Pharmacy Resources Incorporated
1| Date | Classification | Office | Project area |
|---|---|---|---|
| January 29, 2019 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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