FDA Inspection
KDunn and Associates, P.A. dba HealthQuiltKDunn and Associates, P.A. dba HealthQuilt – FDA Inspection, Aug 13, 2020
Record Details
This FDA Inspection record concerns KDunn and Associates, P.A. dba HealthQuilt, with an inspection on August 13, 2020, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- August 13, 2020
- Product Type
- Drugs
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ID · 32924ce4-b425-420b-b95b-c5d29a793ddf
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1127247
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
- Enforcement
- Warning Letter
FDA Citations
7- 21 CFR 312.60Informed consent
- 21 CFR 50.25(a)(6)Compensation, medical treatment in event of injury
- 21 CFR 312.57(a)Records of receipt, shipment, disposition
- 21 CFR 50.20Exculpatory language, waiving of rights
- 21 CFR 50.25(a)(7)Whom to contact
- 21 CFR 50.25(a)(4)Alternate procedures, courses of treatment
- 21 CFR 312.20(a)Failure to submit an IND
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