FDA Inspection 997603 — Homeocare Laboratories, Inc.
The FDA completed an inspection of Homeocare Laboratories, Inc. on January 11, 2017 in Yonkers, NY. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 14 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- January 11, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Yonkers, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1033 | 21 CFR 211.22(a) | Authority lacking to review records, investigate errors |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1725 | 21 CFR 211.134(c) | Examinations documented |
| 1842 | 21 CFR 211.84(d)(1) | Component identity verification |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 1976 | 21 CFR 211.182 | Specific information required in individual logs |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 2033 | 21 CFR 211.194(c) | Testing and standardization of standards et. al. |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 3570 | 21 CFR 211.100(a) | Approval and review of procedures |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4354 | 21 CFR 211.165(d) | Acceptance/Rejection Levels |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |