FDA Inspection
Bio-Nucleonics Inc.Bio-Nucleonics Inc. – FDA Inspection, Mar 23, 2010
Record Details
This FDA Inspection record concerns Bio-Nucleonics Inc., with an inspection on March 23, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Bio-Nucleonics Inc.
- Inspection Date
- March 23, 2010
- Product Type
- Drugs
View Company Profile
ID · d6269c5c-4258-41e4-a0d1-e3efd54aa556
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 651253
- FDA center
- Human Drugs
- Project area
- Postmarket Surv. and Epidemiology
FDA Citations
10- 21 CFR 211.122(d)Label storage access limited to authorized personnel
- 21 CFR 211.188(b)(8)Labeling control records including specimens or copies
- 21 CFR 211.94(c)Containers & Closures Clean, Sterilized, Pyrogen-free
- 21 CFR 211.192Quality control unit review of records
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.194(a)(5)Testing Calculations
- 21 CFR 211.194(d)Laboratory equipment calibration records
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.194(a)(2)Suitability of testing methods verified
- 21 CFR 211.192No written record of investigation
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Other FDA inspections of Bio-Nucleonics Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| November 18, 2008 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Bio-Nucleonics Inc.
- FDA Inspection 547411 - 2008-11-18
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