FDA Inspection
Carie Boyd Pharmaceuticals LLCCarie Boyd Pharmaceuticals LLC – FDA Inspection, Jun 21, 2024
Record Details
This FDA Inspection record concerns Carie Boyd Pharmaceuticals LLC, with an inspection on June 21, 2024, covering drugs.
- Inspection Date
- June 21, 2024
- Product Type
- Drugs
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ID · 1a6c0434-3386-43dc-a5c3-0c0f31dd929f
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1241822
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
5- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.46(b)Equipment for Environmental Control
- 21 CFR 211.67(b)(5)Cleaning SOPs/equipment protection
- 21 CFR 211.94(c)Containers & Closures Clean, Sterilized, Pyrogen-free
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Other FDA inspections of Carie Boyd Pharmaceuticals LLC
6| Date | Classification | Office | Project area |
|---|---|---|---|
| September 8, 2026 | Not classified | Dallas District Office | Drug Quality Assurance |
| July 18, 2025 | Not classified | Dallas District Office | Drug Quality Assurance |
| June 27, 2022 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 12, 2019 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 12, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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