FDA Inspection
Carie Boyd Pharmaceuticals LLCCarie Boyd Pharmaceuticals LLC – FDA Inspection, Dec 12, 2014
Record Details
This FDA Inspection record concerns Carie Boyd Pharmaceuticals LLC, with an inspection on December 12, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- December 12, 2014
- Product Type
- Drugs
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ID · 8003c0ac-4c79-44bc-84e2-3b9c343668ab
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 908025
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
12- 21 CFR 211.42(c)(10)(v)Cleaning System
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.188(b)(8)Labeling control records including specimens or copies
- 21 CFR 211.188(b)(3)Identification of each component or in-process material
- 21 CFR 211.28(a)Clothing appropriate for duties performed
- 21 CFR 211.167(a)Sterility/pyrogen-free testing
- 21 CFR 211.84(d)(6)Microbiological Contamination Exam
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.165(a)Testing and release for distribution
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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 | |
| 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 |
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