Company
United StatesAlcami Carolinas Corporation, Morrisville, NC – FDA Inspections
Inspection records and compliance data for Alcami Carolinas Corporation in Morrisville, North Carolina. 6 FDA inspections on record (1 OAI), 3 Form 483s, last inspected August 11, 2026.
Company Profile
This profile covers Alcami Carolinas Corporation based in Morrisville, North Carolina, United States.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 1
- VAI
- 2
- NAI
- 1
- Unclassified
- 2
- Form 483s
- 3
- Warning letters
- 0
First inspected May 24, 2011. Last inspected August 11, 2026.
Most cited issue areas
- Investigations of discrepancies, failures2 inspections
- Drug product sample1 inspection
- Environmental Monitoring System1 inspection
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 11, 2026 | Not classified | Human Drugs · Drug Quality Assurance | 1330734 |
| March 28, 2025 | OAI | Human Drugs · Generic Drug Evaluation | 1265163 |
| December 6, 2024 | Not classified | Human Drugs | 1258354 |
| March 13, 2023 | VAI | Human Drugs · Drug Quality Assurance | 1201193 |
| October 23, 2014 | VAI | Human Drugs · Drug Quality Assurance | 903656 |
| May 24, 2011 | NAI | Human Drugs · Drug Quality Assurance | 732087 |
FDA documents
Form 483s (2)
EIRs (1)
People (5)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Alcami Carolinas Corporation
FEI Number
1000158582
Address
627 Davis Dr, Morrisville, North Carolina 27560, United States
Country
United States
ID: b3301d1d-4fec-4888-82e6-d950811aab7c