FDA Inspection
WellRx LLCWellRx LLC – FDA Inspection, Nov 19, 2015
Record Details
This FDA Inspection record concerns WellRx LLC, with an inspection on November 19, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- WellRx LLC
- Inspection Date
- November 19, 2015
- Product Type
- Drugs
View Company Profile
ID · f6c5b2a9-60c9-42e3-a7c3-8b54efd69728
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 942002
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Enforcement
- 483 Response
FDA Citations
18- 21 CFR 211.42(c)(10)(v)Cleaning System
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.42(a)Buildings of Suitable Size, Construction, Location
- Drug Field Exam
- 21 CFR 211.167(a)Sterility/pyrogen-free testing
- 21 CFR 211.84(d)(2)Testing Each Component for Conformity with Specs
- 21 CFR 211.84(d)(6)Objectionable microbiological contamination
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.113(b)Validation lacking for sterile drug products
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Other FDA inspections of WellRx LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| November 13, 2017 | Not classified | Chicago District Office |
Other documents for WellRx LLC
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