FDA Inspection 1197967 — Homeocare Laboratories, Inc.
The FDA completed an inspection of Homeocare Laboratories, Inc. on February 21, 2023 in Yonkers, NY. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 10 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- February 21, 2023
- Fiscal Year
- 2023
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Yonkers, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1798 | 21 CFR 211.82(b) | Quarantine Storage of Components |
| 1851 | 21 CFR 211.84(e) | Rejecting When Specifications Not Met |
| 1928 | 21 CFR 211.166(c)(1) | Homeopathic drugs, assessment of stability |
| 1943 | 21 CFR 211.180(e)(1) | Review of representative number of batches |
| 2014 | 21 CFR 211.188(b)(2) | Identification of Equipment and Lines |
| 2028 | 21 CFR 211.192 | Extent of discrepancy, failure investigations |