FDA Inspection 941532 — Ace Surgical Supply Co., Inc.
The FDA completed an inspection of Ace Surgical Supply Co., Inc. on Jul 23, 2015 in Brockton, 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). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 23, 2015
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Brockton, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3283 | 21 CFR 820.90(a) | Specific non-conforming product procedures |
| 486 | 21 CFR 820.50(a) | Evaluation of suppliers, contractors, etc., requirements |
| 633 | 21 CFR 803.17(a)(3) | Lack of System for Timely Submission of Reports |
| 9087 | 21 CFR 600.14(a)(1) | Who must report - receiving information |