FDA Inspection 994008 — MS Bionic
The FDA completed an inspection of MS Bionic on December 5, 2016 in Gardena, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 13 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- December 5, 2016
- Fiscal Year
- 2017
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Gardena, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15531 | 21 CFR 111.255(a) | Batch record - every batch |
| 15584 | 21 CFR 111.155(d)(1) | Components - identify lot produced |
| 15641 | 21 CFR 111.453 | Written procedures - holding |
| 15660 | 21 CFR 111.475(b)(2) | Records - product distribution |
| 15715 | 21 CFR 111.375(b) | Records - manufacturing operations; written procedures |
| 15736 | 21 CFR 111.353 | Manufacturing operations - written procedures |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15829 | 21 CFR 111.70(b)(1) | Specifications - component identity |
| 15830 | 21 CFR 111.70(b)(2) | Specifications-component purity, strength, composition |
| 15831 | 21 CFR 111.70(b)(3) | Specifications - contamination limits |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15862 | 21 CFR 111.75(a)(2) | Appropriate tests, examinations; certificate of analysis |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |