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FDA Inspection
•S.A.E.G.•March 19, 2012

S.A.E.G. – FDA Inspection, Mar 19, 2012

Record Details

This FDA Inspection record concerns S.A.E.G., with an inspection on March 19, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
S.A.E.G.
Inspection Date
March 19, 2012
Product Type
Drugs
Office
Center for Drug Evaluation and Research
View Company Profile

ID · 6ccff792-fe4f-449d-a173-b955e2ad85e4

Inspection Facts

Official Action Indicated (OAI)

Significant objectionable conditions were found and regulatory or administrative action is recommended.

Inspection number
773429
FDA center
Human Drugs
Project area
Drug Quality Assurance

FDA Citations

13
  1. 21 CFR 211.87Retest of approved components/containers/closures
  2. 21 CFR 211.150(b)Recall facilitation
  3. 21 CFR 211.56(a)Sanitation--buildings not clean, free of infestation
  4. 21 CFR 211.28(a)Clothing appropriate for duties performed
  5. 21 CFR 211.198(b)Maintenance of Complaint File
  6. 21 CFR 211.110(a)Control procedures to monitor and validate performance
  7. 21 CFR 211.137(a)Expiration date lacking
  8. 21 CFR 211.84(a)Components withheld from use pending release
  9. 21 CFR 211.25(a)Training , Education , Experience overall
  10. 21 CFR 211.56(c)Rodenticides et. al. registration and usage

Showing 10 of 13 citations.

Full citation text and observation details available on the Dashboard.

Other FDA inspections of S.A.E.G.

2
DateClassificationOfficeProject area
December 5, 2023NAICenter for Drug Evaluation and ResearchDrug Quality Assurance
January 31, 2012OAICenter for Drug Evaluation and ResearchDrug Quality Assurance
Other documents for S.A.E.G.
  • FDA Inspection 1225117 - 2023-12-05
  • FDA Inspection 765676 - 2012-01-31

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