FDA Inspection
Allergan Sales, LLCAllergan Sales, LLC – FDA Inspection, Jul 31, 2026
Record Details
This FDA Inspection record concerns Allergan Sales, LLC, with an inspection on July 31, 2026, issued by the Dallas District Office, covering human drugs.
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ID · 78d79be5-3839-460d-a935-35014e5d0753
Inspection Facts
- Inspection number
- 1316492
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued, view the record
FDA Citations
12- 21 CFR 211.100(b)SOPs not followed / documented
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.42(c)(10)(v)Cleaning System
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
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Other FDA inspections of Allergan Sales, LLC
9| Date | Classification | Office | Project area |
|---|---|---|---|
| March 24, 2022 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 27, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 28, 2016 | VAI | Center for Drug Evaluation and Research | New Drug Evaluation |
| October 8, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 10, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Allergan Sales, LLC
- FDA Inspection 1166865 - 2022-03-24
- FDA Inspection 1080772 - 2019-02-27
- FDA Inspection 991999 - 2016-10-28
- FDA Inspection 947137 - 2015-10-08
- FDA Inspection 937479 - 2015-07-10
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