Alcami Carolinas Corporation
Form 483 issued April 5, 2024 · Charleston, South Carolina
- Investigator
- Rodney L. Tinzie
- Observations
- 1
- Pages
- 2
- FEI number
- 1000110990
In short: On April 5, 2024, FDA issued a Form 483 with 1 observation to Alcami Carolinas Corporation in Charleston, South Carolina (FEI 1000110990). The investigator was Rodney L. Tinzie. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
1 of 1 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.160(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Established specifications and test…
This inspection in context
Rodney L. Tinzie
7 documents · 2023–2026
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in Texas.
The firmAlcami Carolinas Corporation history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.160(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Alcami Carolinas Corporation?
FDA listed 1 observation on this Form 483, mostly about 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?
Rodney L. Tinzie is named on this Form 483. Each investigator has a profile showing what they cite most.
When was Alcami Carolinas Corporation inspected by FDA?
This Form 483 is dated April 5, 2024.
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.