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FDA Inspection
•Wild Child Laboratories Pty Ltd.•June 21, 2024

Wild Child Laboratories Pty Ltd. – FDA Inspection, Jun 21, 2024

Record Details

This FDA Inspection record concerns Wild Child Laboratories Pty Ltd., with an inspection on June 21, 2024, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
Wild Child Laboratories Pty Ltd.
Inspection Date
June 21, 2024
Product Type
Drugs
Office
Center for Drug Evaluation and Research
Person
  • Anastasia M. Shields (FDA Associated Person)
View Company Profile

ID · d776f3ab-b86b-49f1-b9c7-98393e0a8c20

Inspection Facts

Official Action Indicated (OAI)

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

Inspection number
1242880
FDA center
Human Drugs
Project area
Drug Quality Assurance

FDA Citations

7
  1. 21 CFR 211.113(a)Procedures for non-sterile drug products
  2. 21 CFR 211.67(b)(3)Cleaning SOPs/instructions
  3. 21 CFR 211.165(a)Testing and release for distribution
  4. 21 CFR 211.192Investigations of discrepancies, failures
  5. 21 CFR 211.22(d)Procedures not in writing, fully followed
  6. 21 CFR 211.166(a)(3)Valid stability test methods
  7. 21 CFR 211.100(a)Absence of Written Procedures

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Wild Child Laboratories Pty Ltd.

2
DateClassificationOfficeProject area
June 17, 2022OAICenter for Drug Evaluation and ResearchDrug Quality Assurance
May 31, 2019OAICenter for Drug Evaluation and ResearchDrug Quality Assurance
Other documents for Wild Child Laboratories Pty Ltd.
  • FDA Inspection 1172981 - 2022-06-17
  • FDA Inspection 1091244 - 2019-05-31

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