FDA Inspection
Nomax IncNomax Inc – FDA Inspection, Jan 31, 2012
Record Details
This FDA Inspection record concerns Nomax Inc, with an inspection on January 31, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Nomax Inc
- Inspection Date
- January 31, 2012
- Product Type
- Drugs
View Company Profile
ID · f3001ec0-f406-4942-8c50-ada1fd80d973
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 765308
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
9- 21 CFR 211.188(b)(2)Identity of major equipment and lines used
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 820.100(b)Documentation
- 21 CFR 211.170(b)Drug product reserve containers
- 21 CFR 211.160(b)(4)Establishment of calibration procedures
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 211.170(b)Annual visual exams of drug products
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.100(b)SOPs not followed / documented
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Other FDA inspections of Nomax Inc
9| Date | Classification | Office | Project area |
|---|---|---|---|
| February 25, 2026 | Not classified | Kansas City District Office | |
| February 16, 2024 | NAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
| December 2, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 24, 2022 | NAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| February 1, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Nomax Inc
- FDA Inspection 1315328 - 2026-02-25
- FDA Inspection 1229313 - 2024-02-16
- FDA Inspection 1194330 - 2022-12-02
- FDA Inspection 1180777 - 2022-06-24
- FDA Inspection 1042641 - 2018-02-01
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