FDA Inspection
Homeocare Laboratories, Inc.Homeocare Laboratories, Inc. – FDA Inspection, Jun 4, 2021
Record Details
This FDA Inspection record concerns Homeocare Laboratories, Inc., with an inspection on June 4, 2021, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Homeocare Laboratories, Inc.
- Inspection Date
- June 4, 2021
- Product Type
- Drugs
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ID · 48731717-626b-4fc5-aed9-10cf73470ccf
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1144657
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
9- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.42(c)(1)Incoming material area
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.166(c)(1)Homeopathic drugs, assessment of stability
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.67(b)Written procedures not established/followed
- 21 CFR 211.100(b)SOPs not followed / documented
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Other FDA inspections of Homeocare Laboratories, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| March 20, 2024 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 21, 2023 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 23, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 11, 2017 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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