FDA Inspection 876584 — M & B Products LLC
The FDA completed an inspection of M & B Products LLC on April 30, 2014 in Canton, OH. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 19 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 30, 2014
- Fiscal Year
- 2014
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Canton, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15492 | 21 CFR 111.25(a) | Procedures - calibrating instruments |
| 15526 | 21 CFR 111.30(c) | Equipment - automated - calibrate, inspect |
| 15531 | 21 CFR 111.255(a) | Batch record - every batch |
| 15546 | 21 CFR 111.260(f) | Batch record - yield |
| 15550 | 21 CFR 111.260(j) | Batch record - manufacture |
| 15552 | 21 CFR 111.260(j)(2) | Batch record - initials; each step |
| 15557 | 21 CFR 111.260(k) | Batch record - packaging, labeling |
| 15641 | 21 CFR 111.453 | Written procedures - holding |
| 15649 | 21 CFR 111.465(a)(1) | Hold - reserve samples; ordinary storage |
| 15747 | 21 CFR 111.210(g) | Packaging description, representative label |
| 15753 | 21 CFR 111.210(b) | Master manufacturing record - list components |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15777 | 21 CFR 111.415(c) | Filling, assembling, packaging, labeling - sanitary handling |
| 15829 | 21 CFR 111.70(b)(1) | Specifications - component identity |
| 15832 | 21 CFR 111.70(c)(1) | In-process identity, purity, strength, composition |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15861 | 21 CFR 111.75(a)(2)(ii)(A) | Component - qualify supplier |
| 15865 | 21 CFR 111.75(a)(2)(ii)(D) | Re-confirm certificate of analysis |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |