FDA Inspection
Laboratorio Analitico, Inc.Laboratorio Analitico, Inc. – FDA Inspection, Feb 14, 2018
Record Details
This FDA Inspection record concerns Laboratorio Analitico, Inc., with an inspection on February 14, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · a1d8c5ec-9623-40bc-a35b-813ebc333c22
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1043876
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.160(b)(4)Establishment of calibration procedures
- 21 CFR 211.160(b)(4)Instruments, apparatus, et. al. not meeting specs
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Other FDA inspections of Laboratorio Analitico, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| June 10, 2015 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 11, 2013 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 19, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 7, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Laboratorio Analitico, Inc.
- FDA Inspection 929533 - 2015-06-10
- FDA Inspection 821729 - 2013-03-11
- FDA Inspection 759487 - 2011-12-19
- FDA Inspection 708769 - 2011-02-07
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