FDA Inspection
Exelead, Inc.Exelead, Inc. – FDA Inspection, Jun 7, 2011
Record Details
This FDA Inspection record concerns Exelead, Inc., with an inspection on June 7, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Exelead, Inc.
- Inspection Date
- June 7, 2011
- Product Type
- Drugs
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ID · dbacd376-9e66-47b8-b038-cd742241698d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 729308
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
4- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.166(a)Results not used for expiration dates, storage cond.
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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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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