FDA Inspection
Borden Company (Pte) LtdBorden Company (Pte) Ltd – FDA Inspection, May 23, 2025
Record Details
This FDA Inspection record concerns Borden Company (Pte) Ltd, with an inspection on May 23, 2025, issued by the Office of Inspections and Investigations, covering human drugs.
View Company Profile
ID · 73445e78-dcad-4a6a-b569-dc7ffa8eb337
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1270553
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.165(e)Test methods
- 21 CFR 211.22(d)Procedures not in writing, fully followed
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Borden Company (Pte) Ltd
3| Date | Classification | Office | Project area |
|---|---|---|---|
| May 24, 2019 | VAI | Center for Drug Evaluation and Research | 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 1090590 - 2019-05-24
- FDA Inspection 896080 - 2014-09-19
- FDA Inspection 783751 - 2012-05-11
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.