FDA Inspection 767433 — New England Cryogenic Center, Inc.
The FDA completed an inspection of New England Cryogenic Center, Inc. on March 6, 2012 in Marlborough, MA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 6, 2012
- Fiscal Year
- 2012
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Marlborough, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12324 | 21 CFR 1271.160(b)(6) | Deviations--Investigation, documenting, trending |
| 12336 | 21 CFR 1271.180(a) | Procedures to meet core CTGP |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 98 | 21 CFR 606.100(c) | Thorough investigations |