FDA Inspection
Halocarbon Life Sciences, LLCHalocarbon Life Sciences, LLC – FDA Inspection, Nov 3, 2023
Record Details
This FDA Inspection record concerns Halocarbon Life Sciences, LLC, with an inspection on November 3, 2023, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · ba735d89-eb5c-45e7-b329-7c36a6311ca0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1221866
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 514.80(b)(2)(i)Applicant did not submit/sent a late15-Day Initial alert report or wrong format
- 21 CFR 514.80(b)(2)(i)Applicant did not submit/sent a late15-Day Initial alert report or wrong format
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Other FDA inspections of Halocarbon Life Sciences, LLC
5| Date | Classification | Office | Project area |
|---|---|---|---|
| August 22, 2019 | NAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| August 9, 2018 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 4, 2015 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 2, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 23, 2009 | NAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
Other documents for Halocarbon Life Sciences, LLC
- FDA Inspection 1102646 - 2019-08-22
- FDA Inspection 1065126 - 2018-08-09
- FDA Inspection 951174 - 2015-12-04
- FDA Inspection 806290 - 2012-11-02
- FDA Inspection 611759 - 2009-07-23
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