FDA Inspection 808211 — Japan Bio Science Laboratory Co.,Ltd.
The FDA completed an inspection of Japan Bio Science Laboratory Co.,Ltd. on Nov 20, 2012 in Kunisaki. 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). 7 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 20, 2012
- Fiscal Year
- 2013
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Kunisaki (Japan)
Citations
| ID | CFR | Description |
|---|---|---|
| 15498 | 21 CFR 111.27(d) | Equipment - maintain, clean, sanitize |
| 15508 | 21 CFR 111.27(a)(5)(ii) | Refrigerator, freezer - alarm |
| 15526 | 21 CFR 111.30(c) | Equipment - automated - calibrate, inspect |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15865 | 21 CFR 111.75(a)(2)(ii)(D) | Re-confirm certificate of analysis |
| 16038 | 21 CFR 111.605(b) | Records - original, true copies |
| 16068 | 21 CFR 111.35(b)(1)(iii) | Equipment, utensils; maintaining, cleaning, sanitizing |