FDA Inspection 1165020 — Xlear Inc.
The FDA completed an inspection of Xlear Inc. on March 18, 2022 in American Fork, UT. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 9 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 18, 2022
- Fiscal Year
- 2022
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- American Fork, UT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1448 | 21 CFR 211.111 | Establishment of time limitations |
| 1540 | 21 CFR 211.125(a) | Strict control not exercised over labeling issued |
| 1803 | 21 CFR 211.84(b) | Representative Samples Criteria |
| 1926 | 21 CFR 211.166(b) | Adequate number of batches on stability |
| 1942 | 21 CFR 211.180(e) | Records reviewed annually |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4313 | 21 CFR 211.84(c)(6) | Containers Marked to Show Samples Taken |
| 4400 | 21 CFR 211.186(b)(8) | Description of containers, labels, et. al. |