Alcami Carolinas Corporation
Form 483 issued October 29, 2021 · Charleston, South Carolina
- Inspection
- Oct 18 – Oct 29, 2021
- Investigator
- Santos E. Camara
- Observations
- 4
- Pages
- 4
- FEI number
- 1000110990
In short: On October 29, 2021, FDA issued a Form 483 with 4 observations to Alcami Carolinas Corporation in Charleston, South Carolina (FEI 1000110990) after an inspection that ran Oct 18 – Oct 29, 2021. The investigator was Santos E. Camara. Most observations concern laboratory controls and production; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
3 of 4 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.160 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
- 02
The calibration of instruments and gauges is not…
- 03
Test procedures relative to appropriate laboratory testing for…
- 04
Each batch of drug product required to be free of objectionable microorganisms is not tested…
This inspection in context
Santos E. Camara
33 documents · 2015–2026
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in India.
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
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 laboratory controls and production. 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?
Santos E. Camara is named on this Form 483, for the inspection of Oct 18 – Oct 29, 2021. Each investigator has a profile showing what they cite most.
When was Alcami Carolinas Corporation inspected by FDA?
The inspection ran Oct 18 – Oct 29, 2021, and the Form 483 is dated October 29, 2021.
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.