FDA Inspection
Appco Pharma, LLCAppco Pharma, LLC – FDA Inspection, Apr 15, 2019
Record Details
This FDA Inspection record concerns Appco Pharma, LLC, with an inspection on April 15, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · debac5be-64ab-45ab-b764-45c58793eee2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1086303
- FDA center
- Human Drugs
- Project area
- Postmarket Surv. and Epidemiology
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 314.80(c)(2)Late submission of quarterly safety reports
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Appco Pharma, LLC
5| Date | Classification | Office | Project area |
|---|---|---|---|
| February 15, 2018 | Not classified | New Jersey District Office | |
| June 27, 2016 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 21, 2014 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 16, 2014 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 22, 2011 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Appco Pharma, LLC
- FDA Inspection 1042697 - 2018-02-15
- FDA Inspection 979709 - 2016-06-27
- FDA Inspection 892288 - 2014-08-21
- FDA Inspection 862390 - 2014-01-16
- FDA Inspection 759813 - 2011-12-22
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