FDA Inspection
GCP LaboratoriesGCP Laboratories – FDA Inspection, May 13, 2022
Record Details
This FDA Inspection record concerns GCP Laboratories, with an inspection on May 13, 2022, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- GCP Laboratories
- Inspection Date
- May 13, 2022
- Product Type
- Drugs
View Company Profile
ID · 8c396915-6675-4587-a3d3-b85d9ac715b8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1169512
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
7- 21 CFR 211.42(a)Buildings of Suitable Size, Construction, Location
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.113(a)Procedures for non-sterile drug products
- 21 CFR 211.42(c)(4)In-Process Material Area
- 21 CFR 211.188(b)Batch production and Batch Control Record Requirements
- 21 CFR 211.22(a)Authority lacking to review records, investigate errors
Full citation text and observation details available on the Dashboard.
Other FDA inspections of GCP Laboratories
7| Date | Classification | Office | Project area |
|---|---|---|---|
| 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 |
| December 9, 2009 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for GCP Laboratories
- FDA Inspection 1099910 - 2019-08-07
- FDA Inspection 1039235 - 2018-01-10
- FDA Inspection 913182 - 2015-02-04
- FDA Inspection 752460 - 2011-11-04
- FDA Inspection 634442 - 2009-12-09
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