FDA Inspection
ALCON-COUVREUR N.V.ALCON-COUVREUR N.V. – FDA Inspection, Nov 15, 2016
Record Details
This FDA Inspection record concerns ALCON-COUVREUR N.V., with an inspection on November 15, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · daede8ac-d9f1-4903-8250-6c93206fa63e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 997972
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.192Investigations of discrepancies, failures
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Other FDA inspections of ALCON-COUVREUR N.V.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| March 5, 2025 | Not classified | Office of Inspections and Investigations | |
| April 29, 2021 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 9, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 26, 2014 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 29, 2010 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for ALCON-COUVREUR N.V.
- FDA Inspection 1305248 - 2025-03-05
- FDA Inspection 1152317 - 2021-04-29
- FDA Inspection 1126883 - 2018-11-09
- FDA Inspection 874952 - 2014-03-26
- FDA Inspection 645897 - 2010-01-29
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