FDA Inspection
Safecor Health, LLCSafecor Health, LLC – FDA Inspection, Oct 19, 2017
Record Details
This FDA Inspection record concerns Safecor Health, LLC, with an inspection on October 19, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · faca0016-e20b-4535-8c5b-4ea3f59d0fe2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1029869
- FDA center
- Human Drugs
- Project area
- Unapproved and Misbranded Drugs
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 211.165(d)Acceptance criteria for sampling & testing
- 21 CFR 211.100(a)Changes to Procedures Not Reviewed, Approved
- 21 CFR 211.46(b)Equipment for Environmental Control
- 21 CFR 211.84(d)(2)Establish reliability of supplier"s C of A
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.180(e)(1)Review of representative number of batches
- 21 CFR 211.198(a)Reporting of adverse drug experience to FDA
- 21 CFR 211.84(d)(2)Establish reliability of supplier's C of A
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Other FDA inspections of Safecor Health, LLC
5| Date | Classification | Office | Project area |
|---|---|---|---|
| October 28, 2025 | VAI | New England District Office | Drug Quality Assurance |
| June 24, 2024 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 16, 2023 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 27, 2015 | OAI | Center for Drug Evaluation and Research | Unapproved and Misbranded Drugs |
| March 7, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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