FDA Inspection
Curia New Mexico, LLCCuria New Mexico, LLC – FDA Inspection, Jun 28, 2024
Record Details
This FDA Inspection record concerns Curia New Mexico, LLC, with an inspection on June 28, 2024, issued by the Center for Drug Evaluation and Research.
- Company
- Curia New Mexico, LLC
- Inspection Date
- June 28, 2024
View Company Profile
ID · abc57ea7-2af9-4a13-9898-38c0ea59eefb
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1239282
- FDA center
- Human Drugs
- Project area
- New Drug Evaluation
FDA Citations
3- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.42(c)(10)(vi)Equipment to control conditions
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Curia New Mexico, LLC
11| Date | Classification | Office | Project area |
|---|---|---|---|
| February 17, 2023 | Not classified | Denver District Office | |
| March 20, 2020 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 15, 2019 | OAI | Denver District Office | New Drug Evaluation |
| 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 1200953 - 2023-02-17
- FDA Inspection 1121293 - 2020-03-20
- FDA Inspection 1082939 - 2019-03-15
- FDA Inspection 999295 - 2016-12-07
- FDA Inspection 929136 - 2015-06-05
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