FDA Inspection
Haw Par Healthcare LimitedHaw Par Healthcare Limited – FDA Inspection, Aug 19, 2022
Record Details
This FDA Inspection record concerns Haw Par Healthcare Limited, with an inspection on August 19, 2022, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Haw Par Healthcare Limited
- Inspection Date
- August 19, 2022
- Product Type
- Drugs
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ID · 0d1247d8-8338-4bbc-abb0-aefa098ba972
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1177852
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
8- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.142(b)Storage under appropriate conditions
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.111Establishment of time limitations
- 21 CFR 211.100(b)SOPs not followed / documented
- 21 CFR 211.192No written record of investigation
- 21 CFR 211.100(a)Absence of Written Procedures
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Other FDA inspections of Haw Par Healthcare Limited
5| Date | Classification | Office | Project area |
|---|---|---|---|
| September 27, 2024 | VAI | Office of Inspections and Investigations | Drug Quality Assurance |
| March 1, 2019 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 26, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 28, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 29, 2009 | OAI | Center for Drug Evaluation and Research | Postmarket Surv. and Epidemiology |
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