Halocarbon Life Sciences, LLC
Form 483 issued November 3, 2023 · North Augusta, South Carolina
- Inspection
- Oct 30 – Nov 3, 2023
- Investigator
- Dorothy P. Kramer
- Observations
- 1
- Pages
- 3
- FEI number
- 1051805
In short: On November 3, 2023, FDA issued a Form 483 with 1 observation to Halocarbon Life Sciences, LLC in North Augusta, South Carolina (FEI 1051805) after an inspection that ran Oct 30 – Nov 3, 2023. The investigator was Dorothy P. Kramer. The most-cited regulation is 21 CFR 514.80 (records and reports concerning experience with approved new animal drugs).
What FDA observed
Preview: the opening words of each observation- 01
You did not submit a 15-Day NADA/ANADA alert report of adverse drug events that are both…
This inspection in context
Dorothy P. Kramer
9 documents · 2022–2025
Cites 211.22(d) (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Florida.
The firmHalocarbon Life Sciences, LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 514.80(b)(2)(i)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Halocarbon Life Sciences, LLC?
FDA listed 1 observation on this Form 483. The most-cited regulation is 21 CFR 514.80 (records and reports concerning experience with approved new animal drugs). The opening words of each observation are shown on this page.
Who inspected Halocarbon Life Sciences, LLC?
Dorothy P. Kramer is named on this Form 483, for the inspection of Oct 30 – Nov 3, 2023. Each investigator has a profile showing what they cite most.
When was Halocarbon Life Sciences, LLC inspected by FDA?
The inspection ran Oct 30 – Nov 3, 2023, and the Form 483 is dated November 3, 2023.
How do I get the full Form 483 for Halocarbon Life Sciences, LLC?
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.