FDA Inspection 789387 — Mackenzie Company, L.L.C.
The FDA completed an inspection of Mackenzie Company, L.L.C. on Jun 15, 2012 in Bush, LA. 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). 22 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 15, 2012
- Fiscal Year
- 2012
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Bush, LA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15442 | 21 CFR 111.15(b)(1) | Physical plant - clean and sanitary |
| 15453 | 21 CFR 111.16 | Written procedures - cleaning |
| 15462 | 21 CFR 111.20(d)(1)(iv) | Physical plant - temperature, humidity controls |
| 15496 | 21 CFR 111.27(b) | Instruments - calibration |
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15618 | 21 CFR 111.180(b)(1) | Written procedures - components |
| 15619 | 21 CFR 111.180(b)(1) | Written procedures - packaging, labeling received |
| 15641 | 21 CFR 111.453 | Written procedures - holding |
| 15642 | 21 CFR 111.455(a) | Hold - temperature, humidity, light |
| 15745 | 21 CFR 111.210(h)(1) | Instructions; specifications; packaged, labeled |
| 15784 | 21 CFR 111.410(c) | Packaging, labels - master manufacturing record |
| 15796 | 21 CFR 111.430(b) | Records - packaging, labeling operations |
| 15809 | 21 CFR 111.570(b)(1) | Written procedures - product complaint; review, investigate |
| 15825 | 21 CFR 111.65 | Quality control - quality, dietary supplement |
| 15829 | 21 CFR 111.70(b)(1) | Specifications - component identity |
| 15832 | 21 CFR 111.70(c)(1) | In-process identity, purity, strength, composition |
| 15840 | 21 CFR 111.70(e) | Specifications - contamination limits |
| 15843 | 21 CFR 111.70(g) | Specifications - finished packaging, labeling |
| 15891 | 21 CFR 111.80(a) | Components packaging, labels received |
| 15975 | 21 CFR 111.120(e) | Quality control operations - quarantine |
| 16068 | 21 CFR 111.35(b)(1)(iii) | Equipment, utensils; maintaining, cleaning, sanitizing |
| 16070 | 21 CFR 111.35(b)(2) | Document-equipment date of use, maintain, clean, sanitize |