FDA Inspection
Aplicare Products, LLCAplicare Products, LLC – FDA Inspection, Sep 6, 2012
Record Details
This FDA Inspection record concerns Aplicare Products, LLC, with an inspection on September 6, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Aplicare Products, LLC
- Inspection Date
- September 6, 2012
- Product Type
- Drugs
View Company Profile
ID · aee51359-4104-4e54-9c9c-af5b0fd42433
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 797580
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
5- 21 CFR 211.113(a)Procedures for non-sterile drug products
- 21 CFR 211.166(a)Results not used for expiration dates, storage cond.
- 21 CFR 211.160(a)Lab controls established, including changes
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.180(e)(1)Review of representative number of batches
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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 |
| September 2, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| 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 |
Other documents for Aplicare Products, LLC
- FDA Inspection 1204284 - 2023-04-14
- FDA Inspection 1147759 - 2021-08-03
- FDA Inspection 988787 - 2016-09-02
- FDA Inspection 957238 - 2016-01-15
- FDA Inspection 903219 - 2014-11-17
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