FDA Inspection 651253 — Bio-Nucleonics Inc.
The FDA completed an inspection of Bio-Nucleonics Inc. on Mar 23, 2010 in Lake Worth, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 10 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 23, 2010
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Postmarket Surv. and Epidemiology
- Location
- Lake Worth, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1505 | 21 CFR 211.122(d) | Label storage access limited to authorized personnel |
| 1869 | 21 CFR 211.94(c) | Containers & Closures Clean, Sterilized, Pyrogen-free |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |
| 2034 | 21 CFR 211.194(d) | Laboratory equipment calibration records |
| 2402 | 21 CFR 211.194(a)(5) | Testing Calculations |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4372 | 21 CFR 211.188(b)(8) | Labeling control records including specimens or copies |
| 4406 | 21 CFR 211.194(a)(2) | Suitability of testing methods verified |
| 4576 | 21 CFR 211.192 | No written record of investigation |