FDA Inspection 1049215 — Sumacc Foods E.I.R.L.
The FDA completed an inspection of Sumacc Foods E.I.R.L. on Apr 20, 2018 in Lima. 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). 20 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 20, 2018
- Fiscal Year
- 2018
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Lima (Peru)
Citations
| ID | CFR | Description |
|---|---|---|
| 15536 | 21 CFR 111.255(d) | Batch record - originals, copies, electronic |
| 15543 | 21 CFR 111.260(c) | Batch record - date, time; maintenance |
| 15545 | 21 CFR 111.260(e) | Batch record - component; identity, weight |
| 15549 | 21 CFR 111.260(i) | Batch record - specifications |
| 15551 | 21 CFR 111.260(j)(1) | Batch record - date, each step |
| 15552 | 21 CFR 111.260(j)(2) | Batch record - initials; each step |
| 15557 | 21 CFR 111.260(k) | Batch record - packaging, labeling |
| 15558 | 21 CFR 111.260(k)(1) | Batch record - identifier; packaging |
| 15559 | 21 CFR 111.260(k)(1) | Batch record - identifier; labels |
| 15560 | 21 CFR 111.260(k)(2) | Batch record - label |
| 15564 | 21 CFR 111.260(l)(1)(ii) | Batch record - quality control; tests, examinations |
| 15566 | 21 CFR 111.260(l)(3) | Batch record - approved, released, rejected; batch |
| 15567 | 21 CFR 111.260(l)(4) | Batch record - approved, released, rejected |
| 15611 | 21 CFR 111.165(d)(2) | Product received - unique identifier, disposition |
| 15641 | 21 CFR 111.453 | Written procedures - holding |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15796 | 21 CFR 111.430(b) | Records - packaging, labeling operations |
| 15797 | 21 CFR 111.553 | Written procedures - product complaint |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |
| 16042 | 21 CFR 111.503 | Written procedures - returned dietary supplement |