FDA Inspection 1023267 — East Coast Surgical, Inc.
The FDA completed an inspection of East Coast Surgical, Inc. on August 24, 2017 in Elizabethtown, PA. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 9 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- August 24, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Elizabethtown, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2350 | 21 CFR 820.25(b) | Training - Lack of or inadequate procedures |
| 3125 | 21 CFR 820.80(d) | Lack of or inadequate final acceptance procedures |
| 3159 | 21 CFR 820.184 | DHR content |
| 3269 | 21 CFR 820.80(b) | Incoming acceptance records, documentation |
| 3313 | 21 CFR 820.120(d) | Records, DHR {see also 820.184(e)} |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |
| 419 | 21 CFR 820.20(b) | Lack of or inadequate organizational structure |
| 541 | 21 CFR 820.70(c) | Environmental control Lack of or inadequate procedures |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |