FDA Inspection
Curia New Mexico, LLCCuria New Mexico, LLC – FDA Inspection, Mar 15, 2019
Record Details
This FDA Inspection record concerns Curia New Mexico, LLC, with an inspection on March 15, 2019, issued by the Denver District Office, covering human drugs.
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ID · 871d5cad-cb47-42d2-b3de-947e9376cf9c
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1082939
- FDA center
- Human Drugs
- Project area
- New Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.160(a)Deviations from laboratory control requirements
- 21 CFR 211.160(b)(3)Drug product sample
- 21 CFR 211.160(b)(3)Drug products-sampling procedures/specifications
- 21 CFR 211.186(b)(9)Complete instructions, procedures, specifications et. al.
- 21 CFR 211.188(b)(7)Actual yield, % of theoretical yield
- 21 CFR 211.194(a)(4)Complete Test Data
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Other FDA inspections of Curia New Mexico, LLC
11| Date | Classification | Office | Project area |
|---|---|---|---|
| June 28, 2024 | VAI | Center for Drug Evaluation and Research | New Drug Evaluation |
| February 17, 2023 | Not classified | Denver District Office | |
| March 20, 2020 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 7, 2016 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| June 5, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Curia New Mexico, LLC
- FDA Inspection 1239282 - 2024-06-28
- FDA Inspection 1200953 - 2023-02-17
- FDA Inspection 1121293 - 2020-03-20
- FDA Inspection 999295 - 2016-12-07
- FDA Inspection 929136 - 2015-06-05
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