FDA Inspection 1261222 — Accupac, Llc
The FDA completed an inspection of Accupac, Llc on Feb 13, 2026 in Lakewood, NJ. 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). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 13, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Lakewood, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 22801 | 21 CFR 830.310(b) | GUDID Information required for unique device identification. |
| 23019 | ISO 13485:2016 Clause 4.1.2 | Risk-based approach not applied to QMS processes |
| 23142 | ISO 13485:2016 Clause 7.4.1 | Supplier performance not monitored |
| 23167 | ISO 13485:2016 Clause 7.5.6 | Process for production and service provision not validated |