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FDA Inspection
•Avadim Holdings Inc•March 31, 2009

Avadim Holdings Inc – FDA Inspection, Mar 31, 2009

Record Details

This FDA Inspection record concerns Avadim Holdings Inc, with an inspection on March 31, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
Avadim Holdings Inc
Inspection Date
March 31, 2009
Product Type
Drugs
Office
Center for Drug Evaluation and Research
View Company Profile

ID · 3cafed9d-7607-4b76-8264-9e585513a313

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
580182
FDA center
Human Drugs
Project area
Drug Quality Assurance

FDA Citations

4
  1. 21 CFR 211.113(a)Procedures for non-sterile drug products
  2. 21 CFR 211.22(c)Approve or reject procedures or specs
  3. 21 CFR 211.100(a)Absence of Written Procedures
  4. 21 CFR 211.166(a)Lack of written stability program

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Avadim Holdings Inc

3
DateClassificationOfficeProject area
May 22, 2025OAIAtlanta District OfficeDrug Quality Assurance
March 6, 2019NAICenter for Drug Evaluation and ResearchDrug Quality Assurance
November 4, 2016VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
Other documents for Avadim Holdings Inc
  • FDA Inspection 1270610 - 2025-05-22
  • FDA Inspection 1084850 - 2019-03-06
  • FDA Inspection 993645 - 2016-11-04

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