Company
United StatesN-Molecular Inc. d.b.a. SOFIE, Ste 6 Haverhill, MA – FDA Inspections
Inspection records and compliance data for N-Molecular Inc. d.b.a. SOFIE in Ste 6 Haverhill, MA. 5 FDA inspections on record (1 OAI), 3 Form 483s, last inspected November 20, 2024.
Company Profile
This profile covers N-Molecular Inc. d.b.a. SOFIE based in Ste 6 Haverhill, MA, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 1
- VAI
- 4
- NAI
- 0
- Form 483s
- 3
- Warning letters
- 0
First inspected December 11, 2013. Last inspected November 20, 2024.
Most cited issue areas
- Written QA procedures established, followed3 inspections
- Adequate controls (general)1 inspection
- Contact surfaces1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 20, 2024 | VAI | Human Drugs · Drug Quality Assurance | 1250020 |
| May 16, 2019 | VAI | Human Drugs · Drug Quality Assurance | 1089718 |
| February 28, 2018 | OAI | Human Drugs · Drug Quality Assurance | 1042553 |
| August 7, 2015 | VAI | Human Drugs · Drug Quality Assurance | 939620 |
| December 11, 2013 | VAI | Human Drugs · Drug Quality Assurance | 859853 |
FDA documents
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Company Information
Name
N-Molecular Inc. d.b.a. SOFIE
FEI Number
3005693151
Address
11 Rogers Rd, Ste 6 Haverhill, MA 01835-8506, United States
Country
United States
ID: 25e8acb8-229e-4d63-9920-d9a698e11170