FDA Inspection
Allergy & Applicator Depot, LlcAllergy & Applicator Depot, Llc – FDA Inspection, Sep 11, 2024
Record Details
This FDA Inspection record concerns Allergy & Applicator Depot, Llc, with an inspection on September 11, 2024, issued by the New York District Office, covering medical devices & rad health.
- Inspection Date
- September 11, 2024
- Product Type
- Medical Devices & Rad Health
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ID · 33f2f381-e4c7-43d5-97d9-e1c46a7f6537
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1249338
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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