FDA Inspection 1158787 — ProTom International Holding Corporation
The FDA completed an inspection of ProTom International Holding Corporation on Dec 14, 2021 in North Reading, MA. 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). 8 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 14, 2021
- Fiscal Year
- 2022
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- North Reading, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3310 | 21 CFR 820.120(b) | DHR documentation of label release {see also 820.184} |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |
| 3665 | 21 CFR 820.20(b)(3) | Management representative |
| 3668 | 21 CFR 820.20(c) | Management review dates |
| 4059 | 21 CFR 820.22 | Quality Audits - defined intervals |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |
| 5007 | 21 CFR 1002.13 | Failure to submit |
| 5700 | 21 CFR 1002.10 | Failure to submit, distinct marking |