FDA Inspection
Exelead, Inc.Exelead, Inc. – FDA Inspection, Jun 17, 2009
Record Details
This FDA Inspection record concerns Exelead, Inc., with an inspection on June 17, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Exelead, Inc.
- Inspection Date
- June 17, 2009
- Product Type
- Drugs
View Company Profile
ID · 7c5ef33f-c3c0-475e-be6b-6e756282846f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 594557
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
3- 21 CFR 211.100(b)Procedure Deviations Recorded and Justified
- 21 CFR 211.80(a)Written Procedures Not Followed
- 21 CFR 211.67(b)Written procedures fail to include
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Other FDA inspections of Exelead, Inc.
11| Date | Classification | Office | Project area |
|---|---|---|---|
| September 4, 2025 | Not classified | Detroit District Office | |
| December 20, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 30, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 15, 2018 | Not classified | Detroit District Office | |
| April 10, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Exelead, Inc.
- FDA Inspection 1287394 - 2025-09-04
- FDA Inspection 1225603 - 2023-12-20
- FDA Inspection 1062147 - 2018-07-30
- FDA Inspection 1055813 - 2018-05-15
- FDA Inspection 922118 - 2015-04-10
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