FDA Inspection
Amol Pharmaceuticals Private Ltd.Amol Pharmaceuticals Private Ltd. – FDA Inspection, Feb 16, 2018
Record Details
This FDA Inspection record concerns Amol Pharmaceuticals Private Ltd., with an inspection on February 16, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 054b3ad4-51eb-4919-800b-8f8e9d85fe19
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1041368
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
11- 21 CFR 211.100(b)Procedure Deviations Recorded and Justified
- 21 CFR 11Electronic records
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.194(a)(8)Identification of Person Performing Review of Lab Records
- 21 CFR 211.186(b)(9)Complete instructions, procedures, specifications et. al.
- 21 CFR 211.165(e)Test methods
- 21 CFR 211.188(b)(11)Identification of Persons Performing Significant Steps
- 21 CFR 211.186(a)Signature and checking of records -- 2 persons
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Other FDA inspections of Amol Pharmaceuticals Private Ltd.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| March 28, 2025 | Not classified | Office of Inspections and Investigations | |
| September 13, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 5, 2017 | NAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
| May 15, 2012 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
Other documents for Amol Pharmaceuticals Private Ltd.
- FDA Inspection 1265781 - 2025-03-28
- FDA Inspection 1101798 - 2019-09-13
- FDA Inspection 1037842 - 2017-12-05
- FDA Inspection 783531 - 2012-05-15
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