FDA Inspection
OPS International IncOPS International Inc – FDA Inspection, Aug 8, 2025
Record Details
This FDA Inspection record concerns OPS International Inc, with an inspection on August 8, 2025, issued by the Florida District Office, covering human drugs.
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ID · ddc220d8-fa40-4131-9c11-1fed45bed9cd
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1279691
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.42(c)(10)(v)Cleaning System
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Other FDA inspections of OPS International Inc
5| Date | Classification | Office | Project area |
|---|---|---|---|
| September 3, 2026 | Not classified | Florida District Office | Drug Quality Assurance |
| May 29, 2024 | OAI | Drug Quality Assurance | |
| April 13, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 4, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 21, 2013 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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