FDA Inspection
Generitech CorporationGeneritech Corporation – FDA Inspection, Apr 5, 2012
Record Details
This FDA Inspection record concerns Generitech Corporation, with an inspection on April 5, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Generitech Corporation
- Inspection Date
- April 5, 2012
- Product Type
- Drugs
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ID · ca462d2b-dd8e-41d4-aba5-57107ff0775a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 775336
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
10- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.165(b)Microbiological testing
- 21 CFR 211.84(d)(2)Testing Each Component for Conformity with Specs
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.142Written warehousing procedures established/followed
- 21 CFR 211.89Quarantine of Rejected Components et. al.
- 21 CFR 211.166(a)Results not used for expiration dates, storage cond.
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
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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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