FDA Inspection
Curia New Mexico, LLCCuria New Mexico, LLC – FDA Inspection, Mar 12, 2010
Record Details
This FDA Inspection record concerns Curia New Mexico, LLC, with an inspection on March 12, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Curia New Mexico, LLC
- Inspection Date
- March 12, 2010
- Product Type
- Drugs
View Company Profile
ID · b38edc3e-5772-4e98-bfc7-33a55324a573
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 652784
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
7- 21 CFR 211.160(b)(4)Establishment of calibration procedures
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.80(a)Procedures To Be in Writing
- 21 CFR 211.180(e)(2)Items to cover on annual reviews
- 21 CFR 211.100(b)SOPs not followed / documented
Full citation text and observation details available on the Dashboard.
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 |
| 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 |
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 1082939 - 2019-03-15
- FDA Inspection 999295 - 2016-12-07
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