FDA Inspection
GCP LaboratoriesGCP Laboratories – FDA Inspection, Feb 19, 2009
Record Details
This FDA Inspection record concerns GCP Laboratories, with an inspection on February 19, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- GCP Laboratories
- Inspection Date
- February 19, 2009
- Product Type
- Drugs
View Company Profile
ID · abca38cb-6132-4739-8fab-d0ecf5d9c364
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 563778
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
10- 21 CFR 211.167(c)Controlled release dosage form testing
- 21 CFR 211.160(b)(1)Incoming lots - conformance to written specs-
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.194(c)Testing and standardization of standards et. al.
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.165(e)Test methods
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.166(a)(3)Valid stability test methods
- 21 CFR 211.166(a)Written program not followed
- 21 CFR 211.101(a)Batches Formulated to less than 100%
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
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.