FDA Inspection
Drug Houses Of Australia Pte LtdDrug Houses Of Australia Pte Ltd – FDA Inspection, May 3, 2012
Record Details
This FDA Inspection record concerns Drug Houses Of Australia Pte Ltd, with an inspection on May 3, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- May 3, 2012
- Product Type
- Drugs
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ID · ae9d32b3-910b-4a9e-a1f4-c8e7ef8432ee
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 780644
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
7- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.160(b)(4)Establishment of calibration procedures
- 21 CFR 211.113(a)Procedures for non-sterile drug products
- 21 CFR 211.84(d)(1)Identity Testing of Each Component
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.67(b)Written procedures not established/followed
- 21 CFR 211.180(e)(2)Items to cover on annual reviews
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Other FDA inspections of Drug Houses Of Australia Pte Ltd
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 12, 2014 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Drug Houses Of Australia Pte Ltd
- FDA Inspection 894995 - 2014-09-12
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