FDA Inspection
Amoli Organics (A Division of Umedica Laboratories Pvt Ltd)Amoli Organics (A Division of Umedica Laboratories Pvt Ltd) – FDA Inspection, Mar 31, 2017
Record Details
This FDA Inspection record concerns Amoli Organics (A Division of Umedica Laboratories Pvt Ltd), with an inspection on March 31, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- March 31, 2017
- Product Type
- Drugs
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ID · 5ab461eb-2d1b-4b39-9b85-d43847d2a524
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1018720
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.142(b)Storage under appropriate conditions
- 21 CFR 820.30(g)Design validation - software validation not performed
- 21 CFR 211.56(b)Written sanitation procedures not followed
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Amoli Organics (A Division of Umedica Laboratories Pvt Ltd)
5| Date | Classification | Office | Project area |
|---|---|---|---|
| March 4, 2024 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 20, 2018 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 12, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 24, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 30, 2010 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Amoli Organics (A Division of Umedica Laboratories Pvt Ltd)
- FDA Inspection 1231931 - 2024-03-04
- FDA Inspection 1065141 - 2018-07-20
- FDA Inspection 957768 - 2016-02-12
- FDA Inspection 878346 - 2014-04-24
- FDA Inspection 684841 - 2010-09-30
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