FDA Inspection 1119221 — H & A Walters Fulfillment Center LLC.
The FDA completed an inspection of H & A Walters Fulfillment Center LLC. on February 28, 2020 in Gainesville, GA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 10 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 28, 2020
- Fiscal Year
- 2020
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Gainesville, GA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15456 | 21 CFR 111.20(b) | Physical plant - space; equipment, materials |
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 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 |
| 15828 | 21 CFR 111.70(a) | Specifications - manufacturing process |
| 15871 | 21 CFR 111.75(c)(2) | Specifications met - test, examinations; compliance |
| 15984 | 21 CFR 111.123(a)(8) | Quality control - finished batch, distribution |
| 16066 | 21 CFR 111.35(b)(1)(i) | Written procedures - instruments, controls; calibrating |