FDA Inspection
Expert Chemical Analysis, Inc.Expert Chemical Analysis, Inc. – FDA Inspection, Oct 7, 2021
Record Details
This FDA Inspection record concerns Expert Chemical Analysis, Inc., with an inspection on October 7, 2021, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- October 7, 2021
- Product Type
- Drugs
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ID · 82dcda51-11a3-447d-9934-661eb3d4737f
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1153933
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
5- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.68(a)Written calibration / inspection records not kept
- 21 CFR 211.165(e)Test methods
- 21 CFR 211.22(a)Lack of quality control unit
- 21 CFR 211.192No written record of investigation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Expert Chemical Analysis, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| December 21, 2011 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 28, 2011 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 9, 2009 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Expert Chemical Analysis, Inc.
- FDA Inspection 759869 - 2011-12-21
- FDA Inspection 707361 - 2011-01-28
- FDA Inspection 629185 - 2009-11-09
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