FDA Inspection
Pharma Nobis LLCPharma Nobis LLC – FDA Inspection, Apr 24, 2009
Record Details
This FDA Inspection record concerns Pharma Nobis LLC, with an inspection on April 24, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Pharma Nobis LLC
- Inspection Date
- April 24, 2009
- Product Type
- Drugs
View Company Profile
ID · e56e9822-2863-465a-b813-dab035644fca
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 579571
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
8- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.22(a)Approve or reject components, products
- 21 CFR 211.166(a)Written program not followed
- 21 CFR 211.67(b)Written procedures fail to include
- 21 CFR 211.192No written record of investigation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Pharma Nobis LLC
9| Date | Classification | Office | Project area |
|---|---|---|---|
| July 25, 2025 | Not classified | Dallas District Office | |
| March 13, 2020 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 7, 2018 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 26, 2018 | NAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| July 1, 2015 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Pharma Nobis LLC
- FDA Inspection 1254643 - 2025-07-25
- FDA Inspection 1121963 - 2020-03-13
- FDA Inspection 1067901 - 2018-08-07
- FDA Inspection 1061996 - 2018-03-26
- FDA Inspection 934827 - 2015-07-01
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