FDA Inspection
Generitech CorporationGeneritech Corporation – FDA Inspection, Apr 5, 2013
Record Details
This FDA Inspection record concerns Generitech Corporation, with an inspection on April 5, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Generitech Corporation
- Inspection Date
- April 5, 2013
- Product Type
- Drugs
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ID · f105df32-8408-47e3-ace1-3ad558512807
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 825863
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
11- 21 CFR 211.166(b)Adequate number of batches on stability
- 21 CFR 211.42(a)Buildings of Suitable Size, Construction, Location
- 21 CFR 211.100(a)Changes to Procedures Not Reviewed, Approved
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.22(a)Lack of quality control unit
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Other FDA inspections of Generitech Corporation
6| Date | Classification | Office | Project area |
|---|---|---|---|
| September 3, 2024 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 29, 2023 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 28, 2021 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 20, 2018 | NAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| October 6, 2016 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
Other documents for Generitech Corporation
- FDA Inspection 1249618 - 2024-09-03
- FDA Inspection 1220868 - 2023-09-29
- FDA Inspection 1148640 - 2021-07-28
- FDA Inspection 1042344 - 2018-02-20
- FDA Inspection 988957 - 2016-10-06
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