Company
United StatesRotech Healthcare Inc.d/b/a/ First Community Care of Niagara, Woburn, MA – FDA Inspections
Inspection records and compliance data for Rotech Healthcare Inc.d/b/a/ First Community Care of Niagara in Woburn, Massachusetts. 2 FDA inspections on record, last inspected May 15, 2015.
Company Profile
This profile covers Rotech Healthcare Inc.d/b/a/ First Community Care of Niagara based in Woburn, Massachusetts, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 2
- NAI
- 0
- Form 483s
- 0
- Warning letters
- 0
First inspected October 15, 2010. Last inspected May 15, 2015.
Most cited issue areas
- Procedures not in writing, fully followed1 inspection
- Quality control unit review of records1 inspection
- SOPs not followed / documented1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 15, 2015 | VAI | Human Drugs · Drug Quality Assurance | 936596 |
| October 15, 2010 | VAI | Human Drugs · Drug Quality Assurance | 684196 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Rotech Healthcare Inc.d/b/a/ First Community Care of Niagara
FEI Number
3006127351
Address
26 Tower Office Park, Woburn, Massachusetts 01801, United States
Country
United States
ID: 9b5f6cf4-e23a-4cdf-bf62-9c582f300680