FDA Inspection
Alembic Pharmaceuticals LimitedAlembic Pharmaceuticals Limited – FDA Inspection, Oct 26, 2018
Record Details
This FDA Inspection record concerns Alembic Pharmaceuticals Limited, with an inspection on October 26, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 092f81f4-b201-4604-bd2b-3a5158e0544d
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1069852
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.188(b)(5)In-process and laboratory control results
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
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Other FDA inspections of Alembic Pharmaceuticals Limited
7| Date | Classification | Office | Project area |
|---|---|---|---|
| July 26, 2024 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 13, 2020 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 20, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 25, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 20, 2015 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Alembic Pharmaceuticals Limited
- FDA Inspection 1242965 - 2024-07-26
- FDA Inspection 1123365 - 2020-03-13
- FDA Inspection 1048097 - 2018-03-20
- FDA Inspection 967744 - 2016-03-25
- FDA Inspection 921484 - 2015-02-20
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