FDA Inspection
GCP LaboratoriesGCP Laboratories – FDA Inspection, Dec 9, 2009
Record Details
This FDA Inspection record concerns GCP Laboratories, with an inspection on December 9, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- GCP Laboratories
- Inspection Date
- December 9, 2009
- Product Type
- Drugs
View Company Profile
ID · 3e4cae67-49ef-4467-bb9a-35576ade2883
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 634442
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
3- 21 CFR 106.30(b)(3)Stability analysis
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.166(a)Written program not followed
Full citation text and observation details available on the Dashboard.
Other FDA inspections of GCP Laboratories
7| Date | Classification | Office | Project area |
|---|---|---|---|
| May 13, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 7, 2019 | NAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| January 10, 2018 | NAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| February 4, 2015 | NAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| November 4, 2011 | NAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
Other documents for GCP Laboratories
- FDA Inspection 1169512 - 2022-05-13
- FDA Inspection 1099910 - 2019-08-07
- FDA Inspection 1039235 - 2018-01-10
- FDA Inspection 913182 - 2015-02-04
- FDA Inspection 752460 - 2011-11-04
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