FDA Inspection
Aplicare Products, LLCAplicare Products, LLC – FDA Inspection, Sep 2, 2016
Record Details
This FDA Inspection record concerns Aplicare Products, LLC, with an inspection on September 2, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Aplicare Products, LLC
- Inspection Date
- September 2, 2016
- Product Type
- Devices
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ID · d9644777-87f8-4955-b1a0-7b45cc269cde
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 988787
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 211.160(a)Deviations from laboratory control requirements
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Aplicare Products, LLC
10| Date | Classification | Office | Project area |
|---|---|---|---|
| April 14, 2023 | Not classified | New England District Office | |
| August 3, 2021 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 15, 2016 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 17, 2014 | VAI | Center for Drug Evaluation and Research | Unapproved and Misbranded Drugs |
| April 18, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Aplicare Products, LLC
- FDA Inspection 1204284 - 2023-04-14
- FDA Inspection 1147759 - 2021-08-03
- FDA Inspection 957238 - 2016-01-15
- FDA Inspection 903219 - 2014-11-17
- FDA Inspection 876204 - 2014-04-18
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