Alcami Carolinas Corporation
Form 483 issued March 13, 2023 · Morrisville, North Carolina
- Inspection
- Mar 1 – Mar 13, 2023
- Investigator
- Patty P. Kaewussdangkul
- Observations
- 2
- Pages
- 3
- FEI number
- 1000158582
In short: On March 13, 2023, FDA issued a Form 483 with 2 observations to Alcami Carolinas Corporation in Morrisville, North Carolina (FEI 1000158582) after an inspection that ran Mar 1 – Mar 13, 2023. The investigator was Patty P. Kaewussdangkul. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Quality system and laboratory controls account for 2 of 2 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 02
Drug product samples are…
This inspection in context
Patty P. Kaewussdangkul
54 documents · 2006–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Texas.
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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Alcami Carolinas Corporation?
FDA listed 2 observations on this Form 483, mostly about quality system and laboratory controls. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Alcami Carolinas Corporation?
Patty P. Kaewussdangkul is named on this Form 483, for the inspection of Mar 1 – Mar 13, 2023. Each investigator has a profile showing what they cite most.
When was Alcami Carolinas Corporation inspected by FDA?
The inspection ran Mar 1 – Mar 13, 2023, and the Form 483 is dated March 13, 2023.
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.