Company
United StatesMAK PHARMA USA LLC - Inspection Records
Inspection records and compliance data for MAK PHARMA USA LLC in Randolph, New Jersey. 1 FDA inspection on record, 1 Form 483, last inspected December 30, 2024.
Company Profile
This profile covers MAK PHARMA USA LLC based in Randolph, New Jersey, United States.
FDA Inspection History
- FDA inspections
- 1
- OAI
- 0
- VAI
- 1
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 0
Inspected December 30, 2024.
Most cited issue areas
- Written procedures not established/followed1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| December 30, 2024 | VAI | Human Drugs · Drug Quality Assurance | 1257639 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
MAK PHARMA USA LLC
FEI Number
3017721405
Address
8 Middlebury Blvd, Randolph, New Jersey 07869, United States
Country
United States
ID: 05027041-f42d-41db-a2bf-7f03dd114a71