FDA Inspection 1144657 — Homeocare Laboratories Inc.
The FDA completed an inspection of Homeocare Laboratories Inc. on Jun 4, 2021 in Yonkers, NY. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 9 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Jun 4, 2021
- Fiscal Year
- 2021
- 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 |
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1251 | 21 CFR 211.42(c)(1) | Incoming material area |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1928 | 21 CFR 211.166(c)(1) | Homeopathic drugs, assessment of stability |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |