FDA Inspection
Combino Pharm (Malta) LtdCombino Pharm (Malta) Ltd – FDA Inspection, Mar 3, 2017
Record Details
This FDA Inspection record concerns Combino Pharm (Malta) Ltd, with an inspection on March 3, 2017, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · 02cc948c-0e6c-4993-bdb7-f9fdb015ab03
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1006240
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.170(b)Annual visual exams of drug products
- 21 CFR 211.63Equipment Design, Size and Location
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Other FDA inspections of Combino Pharm (Malta) Ltd
2| Date | Classification | Office | Project area |
|---|---|---|---|
| March 10, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 17, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Combino Pharm (Malta) Ltd
- FDA Inspection 1268103 - 2022-03-10
- FDA Inspection 1120331 - 2019-07-17
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