FDA Inspection
Kalman Health & Wellness, Inc.Kalman Health & Wellness, Inc. – FDA Inspection, Jul 21, 2015
Record Details
This FDA Inspection record concerns Kalman Health & Wellness, Inc., with an inspection on July 21, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- July 21, 2015
- Product Type
- Drugs
View Company Profile
ID · d3dbb664-b117-4024-8749-fda8c8a0cf46
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 929162
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
14- 21 CFR 211.87Retest of approved components/containers/closures
- 21 CFR 211.42(c)(10)(v)Cleaning System
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.188Prepared for each batch, include complete information
- 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)Microbiological Contamination Exam
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.28(a)Protective Apparel Not Worn
Showing 10 of 14 citations.
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Kalman Health & Wellness, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 27, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Kalman Health & Wellness, Inc.
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.