FDA inspection
Genzyme Corporation / Genzyme Biosurgery: FDA inspection ending May 6, 2022
FDA inspection 1171374 · No Action Indicated (NAI) · Ridgefield, NJ
Key facts
| Inspection ID | 1171374 |
|---|---|
| Firm | Genzyme Corporation / Genzyme Biosurgery |
| FEI number | 2246315 |
| Address | 1125 Pleasantview Ter |
| City | Ridgefield |
| State | NJ |
| ZIP | 07657-2310 |
| Fiscal year | 2022 |
| Inspection end date | May 6, 2022 |
| Classification | No Action Indicated (NAI) |
| Project area | Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccines and Allergenic Products|Vaccines and Allergenic Products|Vaccines and Allergenic Products|Vaccines and Allergenic Products|Vaccines and Allergenic Products|Vaccines and Allergenic Products|Vaccines and Allergenic Products|Vaccines and Allergenic Products|Vaccines and Allergenic Products|Vaccines and Allergenic Products|Vaccines and Allergenic Products|Vaccines and Allergenic Products|Vaccines and Allergenic Products|Vaccines and Allergenic Products|Vaccines and Allergenic Products|Vaccines and Allergenic Products|Vaccines and Allergenic Products|Vaccines and Allergenic Products|Vaccines and Allergenic Products|Vaccines and Allergenic Products|Vaccines and Allergenic Products|Vaccines and Allergenic Products|Vaccines and Allergenic Products|Vaccines and Allergenic Products|Vaccines and Allergenic Products|Vaccines and Allergenic Products|Vaccines and Allergenic Products|Vaccines and Allergenic Products|Vaccines and Allergenic Products|Vaccines and Allergenic Products|Vaccines and Allergenic Products|Vaccines and Allergenic Products|Vaccines and Allergenic Products|Vaccines and Allergenic 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| Product type | Biologics, Drugs |
At a glance
- None Citations
- None Posted citations
- No Warning letter followed
- Yes Form FDA 483 issued
- No Establishment inspection report (EIR) exists
- 10–99 Inspections at this FEI
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA inspections
FDA inspections are classified as No Action Indicated (NAI), Voluntary Action Indicated (VAI) or Official Action Indicated (OAI). Inspections of individual clinical investigators are not published here.
Source: U.S. Food and Drug Administration (FDA), inspection classification data