FDA Inspection
Custom Analytics LLCCustom Analytics LLC – FDA Inspection, May 5, 2009
Record Details
This FDA Inspection record concerns Custom Analytics LLC, with an inspection on May 5, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Custom Analytics LLC
- Inspection Date
- May 5, 2009
- Product Type
- Drugs
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ID · 6b1ec142-b7f1-4c4e-a7e8-578d110174be
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 581661
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
4- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.194(d)Laboratory equipment calibration records
- 21 CFR 211.194(a)(8)Second person sign off
- 21 CFR 211.160(a)Lab controls established, including changes
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Other FDA inspections of Custom Analytics LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| March 12, 2026 | Not classified | Atlanta District Office | Drug Quality Assurance |
| October 27, 2017 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 11, 2012 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Custom Analytics LLC
- FDA Inspection 1307734 - 2026-03-12
- FDA Inspection 1034054 - 2017-10-27
- FDA Inspection 810524 - 2012-12-11
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