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FDA Inspection
•Dr. Rubin H. Saavedra•March 25, 2009

Dr. Rubin H. Saavedra – FDA Inspection, Mar 25, 2009

Record Details

This FDA Inspection record concerns Dr. Rubin H. Saavedra, with an inspection on March 25, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
Dr. Rubin H. Saavedra
Inspection Date
March 25, 2009
Product Type
Drugs
Office
Center for Drug Evaluation and Research
View Company Profile

ID · 7e95a411-c315-4763-be8f-d8ecc56b5e33

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number
577820
FDA center
Human Drugs
Project area
Bioresearch Monitoring

FDA Citations

4
  1. 21 CFR 312.60FD-1572, protocol compliance
  2. 21 CFR 312.62(b)Case history records- inadequate or inadequate
  3. 21 CFR 312.64(b)Safety reports
  4. 21 CFR 312.62(a)Accountability records

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Dr. Rubin H. Saavedra

2
DateClassificationOfficeProject area
June 16, 2017NAICenter for Drug Evaluation and ResearchBioresearch Monitoring
May 19, 2011VAICenter for Drug Evaluation and ResearchBioresearch Monitoring
Other documents for Dr. Rubin H. Saavedra
  • FDA Inspection 1017391 - 2017-06-16
  • FDA Inspection 727733 - 2011-05-19

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