FDA Inspection
Alk-abello, Inc.Alk-abello, Inc. – FDA Inspection, Sep 23, 2026
Record Details
This FDA Inspection record concerns Alk-abello, Inc., with an inspection on September 23, 2026, issued by the New York District Office, covering biologics.
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ID · ef758033-7283-48ba-96de-131f5b5f327e
Inspection Facts
- Inspection number
- 1323588
- FDA center
- Biologics
- Project area
- Vaccines and Allergenic Products
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.67(b)Written procedures not established/followed
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 610.14Testing
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Other FDA inspections of Alk-abello, Inc.
7| Date | Classification | Office | Project area |
|---|---|---|---|
| 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 |
| October 30, 2018 | 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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