Alcami Carolinas Corporation
FDA inspection history in Morrisville, North Carolina, 2023 to 2025
- 2
- Form 483s
Every document, by year
- Form 483
2023: one Form 483; 2025: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2023–25Two Form 483s, at Morrisville, North Carolina.
- 2025The longest 483 on file: 4 observations over 5 pages at Morrisville, North Carolina.
Cited most
Across all Alcami Carolinas observations on file
- 21 CFR 211.103Calculation of yield1
- 21 CFR 211.111Time limitations on production1
- 21 CFR 211.160General requirements1
- 21 CFR 211.166Stability testing1
- 21 CFR 211.192Production record review1
The complete Alcami Carolinas file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Morrisville, North Carolina
Two Form 483s · 2023 to 2025 · 6 observations
Latest: Form 483, Mar 28, 2025 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-03-28 | 483 Form 483 | Morrisville, North Carolina | 4 | $99 |
| 2023-03-13 | 483 Form 483 | Morrisville, North Carolina | 2 | $99 |
Investigators on these documents
FEI number 1000158582 · most recent document Mar 28, 2025
About Alcami Carolinas Corporation
How many FDA Form 483s has Alcami Carolinas Corporation received?
FDA Intel has 2 Form 483s on file for Alcami Carolinas Corporation; the most recent is dated Mar 28, 2025.
When was Alcami Carolinas Corporation last inspected by FDA?
The most recent FDA inspection document on file for Alcami Carolinas Corporation is a Form 483 dated Mar 28, 2025, for the site in Morrisville, North Carolina.
What did FDA cite at Alcami Carolinas Corporation?
The regulations cited most in the observations on file for Alcami Carolinas Corporation are 21 CFR 211.103 (Calculation of yield), 1 time; 21 CFR 211.111 (Time limitations on production), 1 time; 21 CFR 211.160 (General requirements), 1 time.