FDA Inspection
Immacule Lifesciences Private LimitedImmacule Lifesciences Private Limited – FDA Inspection, Mar 14, 2023
Record Details
This FDA Inspection record concerns Immacule Lifesciences Private Limited, with an inspection on March 14, 2023, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 35cc9e47-0799-468c-ab1f-ba4f3db83e1f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1200247
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.22(c)Approve or reject procedures or specs
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.22(c)Approve or reject procedures or specs
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Other FDA inspections of Immacule Lifesciences Private Limited
3| Date | Classification | Office | Project area |
|---|---|---|---|
| September 18, 2025 | OAI | Monitoring of Marketed Animal Drugs, Feed, and Devices | |
| June 20, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 10, 2019 | Not classified | Office of Inspections and Investigations |
Other documents for Immacule Lifesciences Private Limited
- FDA Inspection 1286150 - 2025-09-18
- FDA Inspection 1174725 - 2022-06-20
- FDA Inspection 1094021 - 2019-05-10
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