FDA Inspection
ALK-Abello, Inc.ALK-Abello, Inc. – FDA Inspection, Mar 1, 2019
Record Details
This FDA Inspection record concerns ALK-Abello, Inc., with an inspection on March 1, 2019, issued by the New England District Office, covering human drugs.
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ID · 661aa8fb-09cc-4bd8-8ed0-7617aa8aa111
Inspection Facts
- Inspection number
- 1080880
- FDA center
- Human Drugs
- Project area
- New Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
15- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.150Written distribution procedure
- 21 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
- 21 CFR 211.166(a)Written program not followed
- 21 CFR 211.188(b)Batch production and Batch Control Record Requirements
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.25(a)Training , Education , Experience overall
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Other FDA inspections of ALK-Abello, Inc.
9| Date | Classification | Office | Project area |
|---|---|---|---|
| June 13, 2025 | OAI | New England District Office | Drug Quality Assurance |
| October 21, 2022 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 3, 2021 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 29, 2018 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| September 19, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for ALK-Abello, Inc.
- FDA Inspection 1272585 - 2025-06-13
- FDA Inspection 1181903 - 2022-10-21
- FDA Inspection 1141073 - 2021-05-03
- FDA Inspection 1073636 - 2018-11-29
- FDA Inspection 1025749 - 2017-09-19
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