FDA Inspection
Qualis Packaging, Inc.Qualis Packaging, Inc. – FDA Inspection, Sep 15, 2016
Record Details
This FDA Inspection record concerns Qualis Packaging, Inc., with an inspection on September 15, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Qualis Packaging, Inc.
- Inspection Date
- September 15, 2016
- Product Type
- Drugs
View Company Profile
ID · 14f04df3-6a3f-43d1-b06a-ec6288f919d1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 987693
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
2- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.194(a)Complete test data included in records
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Qualis Packaging, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| July 24, 2014 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 2, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 17, 2009 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Qualis Packaging, Inc.
- FDA Inspection 889122 - 2014-07-24
- FDA Inspection 794943 - 2012-07-02
- FDA Inspection 613131 - 2009-09-17
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.