FDA Inspection 1229211 — Homeocare Laboratories, Inc.
The FDA completed an inspection of Homeocare Laboratories, Inc. on March 20, 2024 in Yonkers, NY. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 12 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- March 20, 2024
- Fiscal Year
- 2024
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Yonkers, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1162 | 21 CFR 211.28(a) | Protective Apparel Not Worn |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1220 | 21 CFR 211.67(b)(3) | Cleaning SOPs/instructions |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1844 | 21 CFR 211.84(d)(2) | Establish reliability of supplier's C of A |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 2205 | 21 CFR 211.186(b)(9) | Manufacturing Instructions and Specifications |
| 3559 | 21 CFR 211.56(a) | Sanitation--buildings not clean, free of infestation |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4576 | 21 CFR 211.192 | No written record of investigation |