FDA Inspection
Haleon US Inc.Haleon US Inc. – FDA Inspection, Jan 20, 2012
Record Details
This FDA Inspection record concerns Haleon US Inc., with an inspection on January 20, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Haleon US Inc.
- Inspection Date
- January 20, 2012
- Product Type
- Drugs
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ID · 80b356dd-b567-44b3-b3e6-8148c09f185c
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 763095
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
10- 21 CFR 314.81(b)(1)(i)Mix-up
- 21 CFR 211.100(b)Procedure Deviations Recorded and Justified
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.192Extent of discrepancy, failure investigations
- 21 CFR 211.198(a)Procedures to be written and followed
- 21 CFR 211.25(c)Inadequate number of personnel
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.180(e)(2)Items to cover on annual reviews
- 21 CFR 211.192Written record of investigation incomplete
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Other FDA inspections of Haleon US Inc.
12| Date | Classification | Office | Project area |
|---|---|---|---|
| September 11, 2024 | NAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
| September 30, 2021 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 4, 2019 | NAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| May 25, 2017 | NAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| February 22, 2017 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Haleon US Inc.
- FDA Inspection 1229361 - 2024-09-11
- FDA Inspection 1153381 - 2021-09-30
- FDA Inspection 1117667 - 2019-12-04
- FDA Inspection 1013216 - 2017-05-25
- FDA Inspection 1008528 - 2017-02-22
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