FDA Inspection 904958 — Genzyme Corporation
The FDA completed an inspection of Genzyme Corporation on Nov 21, 2014 in Framingham, MA. 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). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 21, 2014
- Fiscal Year
- 2015
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Framingham, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1079 | 21 CFR 211.22(a) | Contract drug products--lack of responsibility |
| 8907 | 21 CFR 314.81(b)(1)(ii) | Contamination, chemical or physical change, deterioration |
| 9086 | 21 CFR 600.14(a)(1) | Who must report - manufacturer |
| 9225 | 21 CFR 606.171 | Biological product deviation report |