FDA Inspection 1157631 — Synchpack Inc.
The FDA completed an inspection of Synchpack Inc. on Nov 29, 2021 in Maple Grove, MN. 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). 6 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 29, 2021
- Fiscal Year
- 2022
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Maple Grove, MN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15662 | 21 CFR 111.303 | Written procedures - laboratory operations |
| 15739 | 21 CFR 111.210(h)(3)(ii)(B) | Components; add, verify |
| 15748 | 21 CFR 111.210(f) | Master manufacturing record theoretical and expected yield |
| 15977 | 21 CFR 111.123(a)(1) | Quality control operations - master manufacturing record, modifications |
| 15986 | 21 CFR 111.123(b)(2) | Quality control - batch, product specifications |