Company
United StatesBraintree, A part of SEBELA Pharmaceuticals, Holbrook, MA – FDA Inspections
Inspection records and compliance data for Braintree, A part of SEBELA Pharmaceuticals in Holbrook, Massachusetts. 7 FDA inspections on record (1 OAI), 1 Form 483, last inspected March 07, 2025.
Company Profile
This profile covers Braintree, A part of SEBELA Pharmaceuticals based in Holbrook, Massachusetts, United States.
FDA Inspection History
- FDA inspections
- 7
- OAI
- 1
- VAI
- 3
- NAI
- 3
- Form 483s
- 1
- Warning letters
- 0
First inspected May 13, 2009. Last inspected March 7, 2025.
Most cited issue areas
- Absence of Written Procedures1 inspection
- Approve or reject procedures or specs1 inspection
- Calibration/Inspection/Checking not done1 inspection
FDA inspections (7)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 7, 2025 | NAI | Human Drugs · Drug Quality Assurance | 1261728 |
| February 28, 2018 | VAI | Human Drugs · Drug Quality Assurance | 1042622 |
| December 13, 2013 | VAI | Human Drugs · Drug Quality Assurance | 858979 |
| January 14, 2013 | NAI | Human Drugs · Drug Quality Assurance | 814842 |
| January 21, 2011 | VAI | Human Drugs · Drug Quality Assurance | 707123 |
| January 22, 2010 | OAI | Human Drugs · Drug Quality Assurance | 639857 |
| May 13, 2009 | NAI | Human Drugs · Drug Quality Assurance | 587383 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Braintree, A part of SEBELA Pharmaceuticals
FEI Number
1000513636
Address
270 Centre St, Holbrook, Massachusetts 02343, United States
Country
United States
ID: e32fa961-98ff-4606-8883-8c382bf240e2