FDA Inspection 853367 — Amazing Sour Sop, Inc.
The FDA completed an inspection of Amazing Sour Sop, Inc. on November 8, 2013 in Margate, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 15 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 8, 2013
- Fiscal Year
- 2014
- Product Type
- Food/Cosmetics
- Project Area
- Pesticides and Chemical Contaminants
- Location
- Margate, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15401 | 21 CFR 111.12(b) | Personnel - quality control operations; identified |
| 15404 | 21 CFR 111.12(c) | Personnel - education, training, experience |
| 15453 | 21 CFR 111.16 | Written procedures - cleaning |
| 15531 | 21 CFR 111.255(a) | Batch record - every batch |
| 15659 | 21 CFR 111.475(b)(1) | Written procedures - holding; distributing |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15809 | 21 CFR 111.570(b)(1) | Written procedures - product complaint; review, investigate |
| 15819 | 21 CFR 111.55 | Production, process controls - implement |
| 15829 | 21 CFR 111.70(b)(1) | Specifications - component identity |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15840 | 21 CFR 111.70(e) | Specifications - contamination limits |
| 15842 | 21 CFR 111.70(f) | Specifications - product received for packaging, labeling |
| 15843 | 21 CFR 111.70(g) | Specifications - finished packaging, labeling |
| 16013 | 21 CFR 111.140(b)(1) | Records - quality control operations; responsibilities |
| 16057 | 21 CFR 111.535(b)(1) | Records - returned dietary supplement: written procedures |