FDA Inspection
Vita Pharmacy, LLC dba Talon Compounding PharmacyVita Pharmacy, LLC dba Talon Compounding Pharmacy – FDA Inspection, Jun 24, 2015
Record Details
This FDA Inspection record concerns Vita Pharmacy, LLC dba Talon Compounding Pharmacy, with an inspection on June 24, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- June 24, 2015
- Product Type
- Drugs
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ID · a342e0cb-e1a9-420e-b9ab-a785fc2a07b3
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 930632
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
13- 21 CFR 211.42(c)(10)(vi)Equipment to control conditions
- 21 CFR 211.42(c)(10)(v)Cleaning System
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.58Buildings not maintained in good state of repair
- 21 CFR 211.28(a)Clothing appropriate for duties performed
- 21 CFR 211.167(a)Sterility/pyrogen-free testing
- 21 CFR 211.192Extent of discrepancy, failure investigations
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.165(e)Test methods
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Other FDA inspections of Vita Pharmacy, LLC dba Talon Compounding Pharmacy
3| Date | Classification | Office | Project area |
|---|---|---|---|
| October 6, 2021 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 3, 2018 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 29, 2016 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Vita Pharmacy, LLC dba Talon Compounding Pharmacy
- FDA Inspection 1153854 - 2021-10-06
- FDA Inspection 1061914 - 2018-08-03
- FDA Inspection 976566 - 2016-06-29
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