FDA Inspection
Berdy & Malhotra PC dba Ophthalmology AssociatesBerdy & Malhotra PC dba Ophthalmology Associates – FDA Inspection, Apr 25, 2014
Record Details
This FDA Inspection record concerns Berdy & Malhotra PC dba Ophthalmology Associates, with an inspection on April 25, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- April 25, 2014
- Product Type
- Drugs
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ID · bedbc513-c002-42a4-91a9-ad8ec75bacf3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 876516
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
2- 21 CFR 812.2(c)Needs IDE; not a legally marketed device
- 21 CFR 312.60FD-1572, protocol compliance
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Other FDA inspections of Berdy & Malhotra PC dba Ophthalmology Associates
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 10, 2015 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
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