FDA Inspection
Quality Care Products, LLCQuality Care Products, LLC – FDA Inspection, Oct 15, 2018
Record Details
This FDA Inspection record concerns Quality Care Products, LLC, with an inspection on October 15, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
View Company Profile
ID · 5f4a9ef1-7f60-42f7-8331-da01b67ae76d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1068718
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.22(a)Authority lacking to review records, investigate errors
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.130(a)Prevention of cross contamination, mix-ups
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Quality Care Products, LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| February 26, 2016 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 2, 2010 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Quality Care Products, LLC
- FDA Inspection 968147 - 2016-02-26
- FDA Inspection 650666 - 2010-03-02
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.