FDA Inspection
Haleon US Inc.Haleon US Inc. – FDA Inspection, Jul 8, 2011
Record Details
This FDA Inspection record concerns Haleon US Inc., with an inspection on July 8, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Haleon US Inc.
- Inspection Date
- July 8, 2011
- Product Type
- Drugs
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ID · 6ab160d6-c13b-456b-b7b2-77362c977d40
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 730856
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
13- 21 CFR 314.81(b)(1)(i)Mix-up
- 21 CFR 211.100(b)Procedure Deviations Recorded and Justified
- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.192Extent of discrepancy, failure investigations
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.105(b)Distinctive ID or code not recorded in batch record
- 21 CFR 211.25(c)Inadequate number of personnel
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.198(a)Complaints reviewed by Quality Control Unit
- 21 CFR 211.192No written record of investigation
Showing 10 of 13 citations.
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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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