Company
United StatesSurgi-Care, Inc., Waltham, MA – FDA Inspections
Inspection records and compliance data for Surgi-Care, Inc. in Waltham, Massachusetts. 5 FDA inspections on record, 1 Form 483, last inspected February 10, 2020.
Company Profile
This profile covers Surgi-Care, Inc. based in Waltham, Massachusetts, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 3
- NAI
- 2
- Form 483s
- 1
- Warning letters
- 0
First inspected January 14, 2009. Last inspected February 10, 2020.
Most cited issue areas
- Procedures and release criteria2 inspections
- Accurate, indelible, legible1 inspection
- Ensuring appropriate core requirements followed1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 10, 2020 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 1120374 |
| January 12, 2017 | VAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 997637 |
| March 10, 2015 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 920502 |
| April 11, 2013 | VAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 828785 |
| January 14, 2009 | VAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 638764 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Surgi-Care, Inc.
FEI Number
3003435341
Address
71 1st Ave, Waltham, Massachusetts 02451, United States
Country
United States
ID: d7c887de-7f31-47af-bd78-719e8fbe8345