FDA Inspection
Laboratorio Analitico, Inc.Laboratorio Analitico, Inc. – FDA Inspection, Feb 7, 2011
Record Details
This FDA Inspection record concerns Laboratorio Analitico, Inc., with an inspection on February 7, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Laboratorio Analitico, Inc.
- Inspection Date
- February 7, 2011
- Product Type
- Drugs
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ID · de6e5420-39fc-4e79-b8fe-b2ffa41b038b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 708769
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
2- 21 CFR 211.160(a)Lab controls established, including changes
- 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 |
|---|---|---|---|
| February 14, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| 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 |
Other documents for Laboratorio Analitico, Inc.
- FDA Inspection 1043876 - 2018-02-14
- FDA Inspection 929533 - 2015-06-10
- FDA Inspection 821729 - 2013-03-11
- FDA Inspection 759487 - 2011-12-19
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