Drug factory · FDA FEI 1051805
Halocarbon Life Sciences, LLC
1100 Dittman Court, North Augusta, SC, United States
Problems found, fixed voluntarily at FDA's last inspection, Nov 3, 2023.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
6 drug inspections on record since 2009: 4 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Isoflurane | Makes it, makes the active ingredient, tests it, packages it and labels it | Halocarbon Life Sciences, LLC | 12164-012 |
| Sevoflurane | Makes it, makes the active ingredient, tests it, packages it and labels it | Boston Biopharma, Halocarbon Life Sciences, LLC | 72163-005, 12164-005 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Nov 3, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Aug 22, 2019 | No problems found | Drug Quality Assurance | — |
| Aug 9, 2018 | No problems found | Drug Quality Assurance | — |
| Dec 4, 2015 | No problems found | Drug Quality Assurance | — |
| Nov 2, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jul 23, 2009 | No problems found | Drug Quality Assurance | — |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Nov 3, 2023 inspection
- Applicant did not submit/sent a late15-Day Initial alert report or wrong format 21 CFR 514.80(b)(2)(i)
You did not submit a 15-Day NADA/ANADA alert report of adverse drug events that are both serious and unexpected within 15 working days of first receiving the information to FDA.
Registered with FDA for: analysis; api manufacture; label; manufacture; pack; relabel; repack.