Alcami Carolinas
United States
Program data pending ClinicalTrials.gov matching
Profiled
Not yet scored
✓ FDA Inspections (7)
○ Clinical Trials
○ SEC Filings
✓ Press (9)
○ EMA GMP
✓ MHRA GMP (6)
✓ HC GMP (29)
Quick Facts: Alcami Carolinas
- Signal Score
- Profiled, not yet scored. Scores are published after regulatory evidence is attached and reviewed. How scoring works
- Headquarters
- United States
- Website
- https://www.alcami.com
- Modalities
- Oral Solid Dose, Sterile Fill-Finish, Small Molecule API
- Active Programs
- No ClinicalTrials.gov matches confirmed
- Data Sources
- FDA Data Dashboard, ClinicalTrials.gov, SEC EDGAR, press monitoring
About Alcami Carolinas
Alcami Carolinas is a contract development and manufacturing organization (CDMO). Capabilities: Oral Solid Dose, Sterile Fill-Finish, Small Molecule API. 8 manufacturing sites registered with the U.S. FDA, the UK MHRA and Health Canada. Website: https://www.alcami.com
Signal Score
Profiled, not yet scored.
Scores are published after regulatory evidence is attached and reviewed.
How scoring works
Alcami Carolinas FDA Inspection History
2026-02
2025-09
2025-01
2024-12
2024-10
2023-03
2021-10
NAI
VAI
OAI
| Date | Site | Type | Observations | Classification |
|---|---|---|---|---|
| 2026-02-06 |
Alcami Carolinas Corporation
Charleston, South Carolina
Company-level
|
Drug Quality Assurance | Yes | Voluntary Action Indicated (VAI) |
| 2025-09-26 |
Alcami Carolinas Corporation
Wilmington, North Carolina
Company-level
|
Drug Quality Assurance | Yes | Voluntary Action Indicated (VAI) |
| 2025-01-31 |
Alcami Carolinas Corporation
Wilmington, North Carolina
Company-level
|
Vaccines and Allergenic Products | Yes | Voluntary Action Indicated (VAI) |
| 2024-12-06 |
Alcami Carolinas Corporation
Morrisville, North Carolina
Company-level
|
Bioresearch Monitoring | No | No Action Indicated (NAI) |
| 2024-10-04 |
Alcami Carolinas Corporation
Saint Louis, Missouri
Company-level
|
Drug Quality Assurance | No | Voluntary Action Indicated (VAI) |
| 2023-03-13 |
Alcami Carolinas Corporation
Morrisville, North Carolina
Company-level
|
Drug Quality Assurance | No | Voluntary Action Indicated (VAI) |
| 2021-10-29 |
Alcami Carolinas Corporation
Charleston, South Carolina
Company-level
|
Drug Quality Assurance | No | Voluntary Action Indicated (VAI) |
Source: FDA Data Dashboard · Retrieved Oct 31, 2026
Alcami Carolinas FDA 483 Findings 18 observations · 2024-04-05 → 2026-04-22 ?
By subsystem
By severity
- 5 — Critical: 1
- 4 — Serious: 1
- 3 — Moderate: 6
- 2 — Minor: 10
- Repeat observations: 2
Most severe findings
-
Second person sign off
"Laboratory records do not include the initials or signature of a second person showing that the original records have been reviewed for accuracy and completeness. Electronic records are used, but they do not meet requirements to ensure that they are trustworthy, reliable and generally equivalent to paper records."
-
Environmental Monitoring System
"Aseptic processing areas are deficient regarding the system for monitoring environmental conditions."
-
Lab controls established, including changes
"The establishment of laboratory control mechanisms including any changes thereto, are not drafted by the appropriate organizational unit and reviewed and approved by the quality control unit."
Alcami Carolinas MHRA GMP Compliance 6 certificates
2016-11
2016-11
2016-11
2016-11
2016-11
2016-11
Compliant
Non-Compliant
| Certificate | Site | City / Postcode | Inspection Date | Status |
|---|---|---|---|---|
| UK GMP 35774 Insp GMP 35774/10895317-0003 [H] | ALCAMI CAROLINAS CORPORATION | 28405 | 2016-11-14 | COMPLIANT |
| UK GMP 35774 Insp GMP 35774/10895317-0003 [V] | ALCAMI CAROLINAS CORPORATION | 28405 | 2016-11-14 | COMPLIANT |
| UK GMP 35774 Insp GMP 35774/13104735-0002 [H] | ALCAMI CAROLINAS CORPORATION | 28405 | 2016-11-14 | COMPLIANT |
| UK GMP 35774 Insp GMP 35774/13104735-0002 [V] | ALCAMI CAROLINAS CORPORATION | 28405 | 2016-11-14 | COMPLIANT |
| UK GMP 35774 Insp GMP 35774/9055077-0003 [H] | ALCAMI CAROLINAS CORPORATION | 28405 | 2016-11-14 | COMPLIANT |
| UK GMP 35774 Insp GMP 35774/9055077-0003 [V] | ALCAMI CAROLINAS CORPORATION | 28405 | 2016-11-14 | COMPLIANT |
Source: MHRA GMDP Database · Retrieved Oct 31, 2026
Hiring Activity Beta
Built from public job postings when a company's own roles can be read. Job postings are signals, not statements by the company; each one below links to the original. How we collect this
No hiring data yet. We haven't found a public jobs feed for this company.
Source:
public careers pages
· Checked Oct 30, 2026
Company Signals 9 articles
Company announcements, not verified evidence. They do not change any score.
Alcami Acquires Tjoapack - Contract Pharma
Alcami to Acquire Contract Packaging Organization Tjoapack - PR Newswire
Alcami Completes Tjoapack Acquisition to Bolster Global Packaging Scale - CHEManager
Alcami Expands Drug Product Manufacturing Capacity to Meet Growing Demand - PR Newswire
Alcami Completes Acquisition of Tjoapack - PR Newswire
CDMO Alcami expands storage capacity at new manufacturing site - BioProcess International
Alcami Expands Out West With Latest Acquisition - WilmingtonBiz
Alcami Brings Third Sterile Fill-Finish Line Online, Expanding Clinical-to-Commercial Capacity - Pharmaceutical Commerce
Alcami invests in quality, packaging and storage upgrades at Tennessee site post-Tjoapack acquisition - Manufacturing Chemist
Frequently Asked Questions About Alcami Carolinas
How many FDA inspections does Alcami Carolinas have on record?
CDMO Signal tracks 7 FDA inspections for Alcami Carolinas, sourced from the FDA inspection database. See the full inspection history above.
Has Alcami Carolinas received an FDA warning letter?
CDMO Signal has no FDA warning letters on record for Alcami Carolinas.
Does Alcami Carolinas hold EMA or MHRA GMP certificates?
CDMO Signal tracks 6 MHRA GMP certificates for Alcami Carolinas.
Does Alcami Carolinas have a CDMO Signal Score?
Not yet. Alcami Carolinas is profiled, not yet scored. Scores are published after regulatory evidence is attached and reviewed.
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