FDA Inspection
Borden Company (Pte) LtdBorden Company (Pte) Ltd – FDA Inspection, May 24, 2019
Record Details
This FDA Inspection record concerns Borden Company (Pte) Ltd, with an inspection on May 24, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · f979b12e-127e-419a-a667-4325b96cb6f8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1090590
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.170(b)Annual visual exams of drug products
- 21 CFR 211.125(a)Strict control not exercised over labeling issued
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.194(a)(2)Laboratory Test Method Verification
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Other FDA inspections of Borden Company (Pte) Ltd
3| Date | Classification | Office | Project area |
|---|---|---|---|
| May 23, 2025 | VAI | Office of Inspections and Investigations | Drug Quality Assurance |
| September 19, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 11, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Borden Company (Pte) Ltd
- FDA Inspection 1270553 - 2025-05-23
- FDA Inspection 896080 - 2014-09-19
- FDA Inspection 783751 - 2012-05-11
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