FDA Inspection
OPS International IncOPS International Inc – FDA Inspection, May 29, 2024
Record Details
This FDA Inspection record concerns OPS International Inc, with an inspection on May 29, 2024, covering drugs.
- Company
- OPS International Inc
- Inspection Date
- May 29, 2024
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ID · ce8e31c7-3e25-4f85-8a8d-0d1fa562f97b
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1237161
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
7- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.165(f)Failing drug products not rejected
- 21 CFR 211.198(a)Procedures to be written and followed
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.42(c)(10)(v)Cleaning System
- FDCA 503B(b)(2)(A)All inclusive product report, not submitted
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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 |
| August 8, 2025 | OAI | Florida District Office | 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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