FDA Inspection
OPS International IncOPS International Inc – FDA Inspection, Sep 3, 2026
Record Details
This FDA Inspection record concerns OPS International Inc, with an inspection on September 3, 2026, issued by the Florida District Office, covering human drugs.
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ID · 9fdbdd8b-8c59-4ed5-8fcf-e6be07384668
Inspection Facts
- Inspection number
- 1332156
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.100(b)SOPs not followed / documented
- 21 CFR 211.101(d)Verification of component addition
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.166(a)(3)Valid stability test methods
- 21 CFR 211.42(c)(10)Aseptic Processing Area
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.84(d)(2)Component written specification
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Other FDA inspections of OPS International Inc
5| Date | Classification | Office | Project area |
|---|---|---|---|
| August 8, 2025 | OAI | 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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