FDA Inspection
Alk-abello, Inc.Alk-abello, Inc. – FDA Inspection, Oct 30, 2018
Record Details
This FDA Inspection record concerns Alk-abello, Inc., with an inspection on October 30, 2018, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · d105b772-4421-48ce-8f0a-7e71bafd7c1c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1070323
- FDA center
- Biologics
- Project area
- Vaccines and Allergenic Products
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.113(b)Validation lacking for sterile drug products
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Other FDA inspections of Alk-abello, Inc.
7| Date | Classification | Office | Project area |
|---|---|---|---|
| September 23, 2026 | Not classified | New York District Office | Vaccines and Allergenic Products |
| October 17, 2023 | VAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| March 9, 2023 | VAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| December 21, 2016 | VAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| February 25, 2014 | VAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
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