FDA Inspection
Encube Ethicals Pvt. Ltd.Encube Ethicals Pvt. Ltd. – FDA Inspection, Jun 11, 2019
Record Details
This FDA Inspection record concerns Encube Ethicals Pvt. Ltd., with an inspection on June 11, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 465129e4-71a3-4572-a46a-098c9eff7338
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1093369
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.160(b)(4)Instruments, apparatus, et. al. not meeting specs
- 21 CFR 211.198(a)Complaints reviewed by Quality Control Unit
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Encube Ethicals Pvt. Ltd.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| June 17, 2024 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 28, 2018 | Not classified | Office of Inspections and Investigations | |
| August 27, 2015 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 23, 2012 | NAI | Center for Food Safety and Applied Nutrition | Colors and Cosmetics Technology |
Other documents for Encube Ethicals Pvt. Ltd.
- FDA Inspection 1240618 - 2024-06-17
- FDA Inspection 1070007 - 2018-09-28
- FDA Inspection 943652 - 2015-08-27
- FDA Inspection 776989 - 2012-03-23
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