FDA Inspection
Caplin Steriles LimitedCaplin Steriles Limited – FDA Inspection, Oct 28, 2016
Record Details
This FDA Inspection record concerns Caplin Steriles Limited, with an inspection on October 28, 2016, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · 62ec8486-3de7-49f0-a9f3-5e55acfcd79f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 991296
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.194(a)(4)Complete Test Data
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
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Other FDA inspections of Caplin Steriles Limited
5| Date | Classification | Office | Project area |
|---|---|---|---|
| August 21, 2026 | Not classified | Office of Inspections and Investigations | Drug Quality Assurance |
| August 9, 2024 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| May 31, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 14, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 6, 2018 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Caplin Steriles Limited
- FDA Inspection 1332422 - 2026-08-21
- FDA Inspection 1251882 - 2024-08-09
- FDA Inspection 1206610 - 2023-05-31
- FDA Inspection 1093164 - 2019-06-14
- FDA Inspection 1069411 - 2018-09-06
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