FDA Inspection
PharOs MT Ltd.PharOs MT Ltd. – FDA Inspection, Apr 13, 2012
Record Details
This FDA Inspection record concerns PharOs MT Ltd., with an inspection on April 13, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- PharOs MT Ltd.
- Inspection Date
- April 13, 2012
- Product Type
- Drugs
View Company Profile
ID · 2c7ce4f2-be92-4b38-a6b8-6330c1ac8bb0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 782552
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
3- 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 PharOs MT Ltd.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| February 9, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 11, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 17, 2009 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for PharOs MT Ltd.
- FDA Inspection 1005501 - 2017-02-09
- FDA Inspection 877728 - 2014-04-11
- FDA Inspection 617326 - 2009-09-17
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