FDA Inspection
Oman Pharmaceutical Products Co. LLCOman Pharmaceutical Products Co. LLC – FDA Inspection, Apr 5, 2018
Record Details
This FDA Inspection record concerns Oman Pharmaceutical Products Co. LLC, with an inspection on April 5, 2018, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · 1fa6674f-0d0b-4f6c-b3e1-9ea025ebda55
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1047398
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.100(b)Procedure Deviations Recorded and Justified
- 21 CFR 211.122(d)Label storage access limited to authorized personnel
- 21 CFR 211.84(c)(3)Sterile Equipment, Aseptic Techniques in sample collecting
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Other FDA inspections of Oman Pharmaceutical Products Co. LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| January 25, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 8, 2020 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 24, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Oman Pharmaceutical Products Co. LLC
- FDA Inspection 1267405 - 2023-01-25
- FDA Inspection 1154327 - 2020-02-08
- FDA Inspection 969074 - 2016-03-24
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