FDA Inspection 1014237 — Esteem Products LTD
The FDA completed an inspection of Esteem Products LTD on June 15, 2017 in Duvall, WA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 15, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Unapproved and Misbranded Drugs
- Location
- Duvall, WA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15620 | 21 CFR 111.180(b)(1) | Written procedures - product received |
| 15658 | 21 CFR 111.475(a) | Records - holding, distribution: readily available |
| 15659 | 21 CFR 111.475(b)(1) | Written procedures - holding; distributing |
| 15809 | 21 CFR 111.570(b)(1) | Written procedures - product complaint; review, investigate |
| 15841 | 21 CFR 111.70(f) | Specifications - product received for packaging, labeling |
| 16013 | 21 CFR 111.140(b)(1) | Records - quality control operations; responsibilities |