Alcami Carolinas Corporation
Form 483 issued March 28, 2025 · Morrisville, North Carolina
- Inspection
- Mar 24 – Mar 28, 2025
- Investigator
- Karthik M. Krishnan
- Observations
- 4
- Pages
- 5
- FEI number
- 1000158582
In short: On March 28, 2025, FDA issued a Form 483 with 4 observations to Alcami Carolinas Corporation in Morrisville, North Carolina (FEI 1000158582) after an inspection that ran Mar 24 – Mar 28, 2025. The investigator was Karthik M. Krishnan. Most observations concern quality system and facilities & equipment.
At a glance
Observations span 4 systems, led by quality system.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The responsibilities and procedures applicable to the quality control unit are not in…
- 02
Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils…
- 03
There is no written testing program designed to assess the stability…
- 04
Time limits are not established when appropriate for the completion of each production phase to assure…
This inspection in context
Karthik M. Krishnan
1 document · 2025
Cites 211.111 (time limitations on production) more than any other section. Most of their documents are for sites in North Carolina.
The firmAlcami Carolinas Corporation history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Alcami Carolinas Corporation?
FDA listed 4 observations on this Form 483, mostly about quality system, facilities & equipment and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Alcami Carolinas Corporation?
Karthik M. Krishnan is named on this Form 483, for the inspection of Mar 24 – Mar 28, 2025. Each investigator has a profile showing what they cite most.
When was Alcami Carolinas Corporation inspected by FDA?
The inspection ran Mar 24 – Mar 28, 2025, and the Form 483 is dated March 28, 2025.
How do I get the full Form 483 for Alcami Carolinas Corporation?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.