FDA Inspection
Hikma Pharmaceuticals USA Inc.Hikma Pharmaceuticals USA Inc. – FDA Inspection, Jun 14, 2013
Record Details
This FDA Inspection record concerns Hikma Pharmaceuticals USA Inc., with an inspection on June 14, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- June 14, 2013
- Product Type
- Drugs
View Company Profile
ID · c7599019-3c0d-4307-9d47-e4a7d0cbf90d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 837934
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
4- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Hikma Pharmaceuticals USA Inc.
18| Date | Classification | Office | Project area |
|---|---|---|---|
| May 13, 2026 | Not classified | New Jersey District Office | |
| June 12, 2024 | VAI | Drug Quality Assurance | |
| November 3, 2023 | VAI | Drug Quality Assurance | |
| July 7, 2022 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 10, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Hikma Pharmaceuticals USA Inc.
- FDA Inspection 1304368 - 2026-05-13
- FDA Inspection 1237333 - 2024-06-12
- FDA Inspection 1222115 - 2023-11-03
- FDA Inspection 1176451 - 2022-07-07
- FDA Inspection 1106822 - 2019-09-10
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.