FDA Inspection
Spectral Data Services, Inc.Spectral Data Services, Inc. – FDA Inspection, Jul 28, 2025
Record Details
This FDA Inspection record concerns Spectral Data Services, Inc., with an inspection on July 28, 2025, issued by the Chicago District Office, covering human drugs.
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ID · 23c67e8f-1d04-4e98-85cf-b6a03c91fcd8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1276969
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
4- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.192Written record of investigation incomplete
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Other FDA inspections of Spectral Data Services, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| May 31, 2016 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 15, 2013 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 3, 2010 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 3, 2009 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Spectral Data Services, Inc.
- FDA Inspection 981787 - 2016-05-31
- FDA Inspection 827322 - 2013-04-15
- FDA Inspection 696314 - 2010-11-03
- FDA Inspection 560458 - 2009-02-03
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