FDA Inspection
Haleon US Inc.Haleon US Inc. – FDA Inspection, Feb 14, 2013
Record Details
This FDA Inspection record concerns Haleon US Inc., with an inspection on February 14, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Haleon US Inc.
- Inspection Date
- February 14, 2013
- Product Type
- Drugs
View Company Profile
ID · e7828a0a-b883-4c55-9a17-470016e9818a
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 820634
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
9- 21 CFR 314.81(b)(1)(ii)Failure to meet specifications
- 21 CFR 211.94(b)Protection from external factors
- 21 CFR 211.100(b)Procedure Deviations Recorded and Justified
- 21 CFR 211.192Extent of discrepancy, failure investigations
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.180(e)(1)Review of representative number of batches
- 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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