FDA Inspection
GMP Laboratories of America IncGMP Laboratories of America Inc – FDA Inspection, Jan 20, 2010
Record Details
This FDA Inspection record concerns GMP Laboratories of America Inc, with an inspection on January 20, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- January 20, 2010
- Product Type
- Drugs
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ID · 765e1467-5a82-480e-8db3-bd79f1f808d3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 639684
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
17- 21 CFR 211.56(a)Sanitation--buildings not clean, free of infestation
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.165(b)Microbiological testing
- 21 CFR 211.101(d)Component release checked by 2nd person
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.194(a)(8)Second person sign off
- 21 CFR 211.188(b)(2)Identification of Equipment and Lines
- 21 CFR 111.15(f)(5)Plumbing - backflow, cross connection
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Other FDA inspections of GMP Laboratories of America Inc
5| Date | Classification | Office | Project area |
|---|---|---|---|
| December 16, 2024 | VAI | Los Angeles District Office | Drug Quality Assurance |
| January 14, 2020 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 28, 2017 | NAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| September 25, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 29, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for GMP Laboratories of America Inc
- FDA Inspection 1256389 - 2024-12-16
- FDA Inspection 1115118 - 2020-01-14
- FDA Inspection 1029037 - 2017-09-28
- FDA Inspection 850294 - 2013-09-25
- FDA Inspection 774909 - 2012-03-29
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