FDA Inspection
Homeocare Laboratories, Inc.Homeocare Laboratories, Inc. – FDA Inspection, Mar 20, 2024
Record Details
This FDA Inspection record concerns Homeocare Laboratories, Inc., with an inspection on March 20, 2024, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 383a06ea-8b63-44fd-bceb-42db2acbe1a6
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1229211
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
13- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.56(a)Sanitation--buildings not clean, free of infestation
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.84(d)(2)Establish reliability of supplier"s C of A
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.67(b)(3)Cleaning SOPs/instructions
- 21 CFR 211.28(a)Protective Apparel Not Worn
- 21 CFR 211.165(e)Test methods
- 21 CFR 211.186(b)(9)Manufacturing Instructions and Specifications
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Other FDA inspections of Homeocare Laboratories, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| February 21, 2023 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 4, 2021 | 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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