FDA Inspection 584284 — M.A.Z.E. Laboratories
The FDA completed an inspection of M.A.Z.E. Laboratories on May 28, 2009 in Purchase, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 28, 2009
- Fiscal Year
- 2009
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Purchase, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12301 | 21 CFR 1271.150(c)(1)(iii) | Ensurane of compliance |
| 12309 | 21 CFR 1271.160(a) | Program is appropriate for the HCT/Ps |
| 12489 | 21 CFR 1271.90(c)(1) | Autologous use only--labeling |