FDA Inspection
OPS International IncOPS International Inc – FDA Inspection, Mar 21, 2013
Record Details
This FDA Inspection record concerns OPS International Inc, with an inspection on March 21, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- OPS International Inc
- Inspection Date
- March 21, 2013
- Product Type
- Drugs
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ID · be5397bd-1c5e-4d37-8f00-275cdf689028
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 825265
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
12- 21 CFR 211.42(c)(10)(iii)Air Supply
- 21 CFR 211.42(c)(10)(v)Cleaning System
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.28(a)Clothing appropriate for duties performed
- 21 CFR 211.94(c)Containers & Closures Clean, Sterilized, Pyrogen-free
- 21 CFR 211.167(a)Sterility/pyrogen-free testing
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.42(c)(10)Aseptic Processing Area
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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 | |
| 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 |
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