FDA Inspection
Carie Boyd Pharmaceuticals LLCCarie Boyd Pharmaceuticals LLC – FDA Inspection, Jun 27, 2022
Record Details
This FDA Inspection record concerns Carie Boyd Pharmaceuticals LLC, with an inspection on June 27, 2022, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- June 27, 2022
- Product Type
- Drugs
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ID · f72e078f-a8ee-4006-883d-78234f6f2c9f
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1172848
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
10- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.188(b)(1)Dates not included for each significant step
- 21 CFR 211.94(c)Containers & Closures Clean, Sterilized, Pyrogen-free
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- Container label, outsourcer facility
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.80(a)Procedures To Be in Writing
- Outsourcing facility, compounded drug report follow up
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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 21, 2024 | OAI | 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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