FDA Inspection 1008513 — Maser Industries, LLC
The FDA completed an inspection of Maser Industries, LLC on April 6, 2017 in Lenexa, KS. 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
- April 6, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Lenexa, KS (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1173 | 21 CFR 110.40(f) | Q.C. instrument accuracy, maintenance |
| 15410 | 21 CFR 111.14(b)(2) | Personnel - records - training |
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15763 | 21 CFR 111.205(a) | Master manufacturing record - unique formulation |
| 15897 | 21 CFR 111.83(a) | Reserve sample - collect, hold |
| 1665 | 21 CFR 110.80(a)(2) | Pasteurization or other adequate treatment |
| 3071 | 21 CFR 114.80(a)(1) | Scheduled process |
| 3078 | 21 CFR 114.80(b) | Code - required elements |
| 4470 | 21 CFR 108.25(c)(2) | Process filing |