FDA Inspection
Kappa Laboratories, Inc.Kappa Laboratories, Inc. – FDA Inspection, Jun 4, 2025
Record Details
This FDA Inspection record concerns Kappa Laboratories, Inc., with an inspection on June 4, 2025, issued by the Florida District Office, covering human drugs.
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ID · 9853688b-01f8-440c-b06c-898d27ae2c6f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1271683
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
3- 21 CFR 211.160(b)(4)Establishment of calibration procedures
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.192No written record of investigation
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Other FDA inspections of Kappa Laboratories, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| April 22, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 25, 2017 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Kappa Laboratories, Inc.
- FDA Inspection 1167681 - 2022-04-22
- FDA Inspection 1029683 - 2017-08-25
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