Alcami Carolinas Corporation
Form 483 issued December 15, 2017 · Charleston, South Carolina
- Inspection
- Dec 11 – Dec 15, 2017
- Investigators
- Larry K. Hampton· Zhao Wang
- Observations
- 2
- Pages
- 3
- FEI number
- 1000110990
In short: On December 15, 2017, FDA issued a Form 483 with 2 observations to Alcami Carolinas Corporation in Charleston, South Carolina (FEI 1000110990) after an inspection that ran Dec 11 – Dec 15, 2017. The investigators were Larry K. Hampton and Zhao Wang. Most observations concern quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
2 of 2 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (1×) · 211.22 (1×)
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
The responsibilities and procedures applicable to the quality…
This inspection in context
Larry K. Hampton
2 documents · 2017–2018
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in South Carolina.
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 211.192
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. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Alcami Carolinas Corporation?
Larry K. Hampton and Zhao Wang are named on this Form 483, for the inspection of Dec 11 – Dec 15, 2017. Each investigator has a profile showing what they cite most.
When was Alcami Carolinas Corporation inspected by FDA?
The inspection ran Dec 11 – Dec 15, 2017, and the Form 483 is dated December 15, 2017.
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.