FDA Inspection 1170105 — ANFALA, INC.
The FDA completed an inspection of ANFALA, INC. on May 20, 2022 in Sarasota, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 11 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 20, 2022
- Fiscal Year
- 2022
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Sarasota, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15491 | 21 CFR 111.25 | Equipment - procedures |
| 15531 | 21 CFR 111.255(a) | Batch record - every batch |
| 15573 | 21 CFR 111.153 | Written procedures - product received; packaging, labeling |
| 15659 | 21 CFR 111.475(b)(1) | Written procedures - holding; distributing |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15790 | 21 CFR 111.403 | Written procedures - labeling operations |
| 15791 | 21 CFR 111.403 | Written procedures -packaging operations |
| 15809 | 21 CFR 111.570(b)(1) | Written procedures - product complaint; review, investigate |
| 15819 | 21 CFR 111.55 | Production, process controls - implement |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |
| 16057 | 21 CFR 111.535(b)(1) | Records - returned dietary supplement: written procedures |