FDA Inspection
Safecor Health, LLCSafecor Health, LLC – FDA Inspection, Mar 16, 2023
Record Details
This FDA Inspection record concerns Safecor Health, LLC, with an inspection on March 16, 2023, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · e8c711b1-760f-4aa9-b43d-8b1455295552
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1200011
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
12- 21 CFR 211.198(b)(2)Complaint Investigation/Follow-Up Findings
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.84(d)(2)Establish reliability of supplier"s C of A
- 21 CFR 211.130(e)Packaging line inspection before use
- 21 CFR 211.186(a)Master production and control records, procedure
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.130(e)Packaging line inspection before use
- 21 CFR 211.186(a)Master production and control records, procedure
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.198(b)(2)Complaint Investigation/Follow-Up Findings
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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 |
| October 19, 2017 | VAI | Center for Drug Evaluation and Research | Unapproved and Misbranded Drugs |
| 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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