FDA Inspection
Caplin Steriles LimitedCaplin Steriles Limited – FDA Inspection, Aug 21, 2026
Record Details
This FDA Inspection record concerns Caplin Steriles Limited, with an inspection on August 21, 2026, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · bd3e5faa-c83c-475e-bde8-3836d72c0b7d
Inspection Facts
- Inspection number
- 1332422
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
10- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.42(c)Defined areas of adequate size for operations
- 21 CFR 211.42(c)(10)(v)Cleaning System
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- FDCA 582(e)(4)Systems in place to comply with verification requirements
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Other FDA inspections of Caplin Steriles Limited
5| Date | Classification | Office | Project area |
|---|---|---|---|
| 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 |
| October 28, 2016 | VAI | Office of Inspections and Investigations | Generic Drug Evaluation |
Other documents for Caplin Steriles Limited
- FDA Inspection 1251882 - 2024-08-09
- FDA Inspection 1206610 - 2023-05-31
- FDA Inspection 1093164 - 2019-06-14
- FDA Inspection 1069411 - 2018-09-06
- FDA Inspection 991296 - 2016-10-28
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