FDA Inspection
OPS International IncOPS International Inc – FDA Inspection, Apr 13, 2018
Record Details
This FDA Inspection record concerns OPS International Inc, with an inspection on April 13, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 28b76a73-ad9d-4a63-a28c-eb1f860d736e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1048185
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 211.42(c)(10)(v)Cleaning System
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.28(a)Protective Apparel Not Worn
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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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 |
| May 29, 2024 | OAI | 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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