FDA Inspection
Caplin Steriles LimitedCaplin Steriles Limited – FDA Inspection, Jun 14, 2019
Record Details
This FDA Inspection record concerns Caplin Steriles Limited, with an inspection on June 14, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · bcb59cec-76e3-456b-9415-2b83a715b2a1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1093164
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.113(b)Procedures for sterile drug products
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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 |
| September 6, 2018 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 28, 2016 | VAI | Office of Inspections and Investigations | Generic Drug Evaluation |
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 1069411 - 2018-09-06
- FDA Inspection 991296 - 2016-10-28
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