FDA Inspection
Exelead, Inc.Exelead, Inc. – FDA Inspection, Apr 10, 2015
Record Details
This FDA Inspection record concerns Exelead, Inc., with an inspection on April 10, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Exelead, Inc.
- Inspection Date
- April 10, 2015
- Product Type
- Drugs
View Company Profile
ID · 7d7fcaf6-d5bd-4142-8bd6-d14c7a28fcba
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 922118
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
5- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.113(b)Procedures for sterile drug products
- 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 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 | |
| May 16, 2014 | 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 878732 - 2014-05-16
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