FDA Inspection
Hikma Pharmaceuticals USA INC.Hikma Pharmaceuticals USA INC. – FDA Inspection, Oct 21, 2016
Record Details
This FDA Inspection record concerns Hikma Pharmaceuticals USA INC., with an inspection on October 21, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- People
- Benjamin J. Dastoli (FDA Associated Person)
- Brian D. Rogers (Issuing Officer)
- Chiaochun J. Wang (Issuing Officer)
- Matthew B. Casale (FDA Associated Person)
View Company Profile
ID · 58697428-2935-48d0-b35b-b970969af19d
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 994023
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.110(b)In-process materials specifications
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 820.30(f)Design verification - output does not meet input requirement
- 21 CFR 820.30(g)Design validation acceptance criteria
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
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Other FDA inspections of Hikma Pharmaceuticals USA INC.
27| Date | Classification | Office | Project area |
|---|---|---|---|
| September 18, 2026 | Not classified | Cincinnati District Office | |
| April 30, 2026 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 17, 2025 | Not classified | Cincinnati District Office | |
| July 23, 2024 | NAI | Compliance: Devices | |
| September 15, 2022 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Hikma Pharmaceuticals USA INC.
- FDA Inspection 1285748 - 2026-09-18
- FDA Inspection 1303412 - 2026-04-30
- FDA Inspection 1238509 - 2025-01-17
- FDA Inspection 1243797 - 2024-07-23
- FDA Inspection 1182363 - 2022-09-15
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