FDA Inspection 808425 — Baxter Healthcare Corporation
The FDA completed an inspection of Baxter Healthcare Corporation on Nov 16, 2012 in Marion, NC. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 10 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Nov 16, 2012
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Marion, NC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1227 | 21 CFR 211.67(c) | Cleaning/maintenance records not kept |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 3547 | 21 CFR 211.46(b) | Equipment for Environmental Control |
| 3562 | 21 CFR 211.56(c) | Written procedures lacking for use of pesticides etc. |
| 3591 | 21 CFR 211.110(b) | In-process materials specifications |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4303 | 21 CFR 211.67(b) | Written procedures fail to include |
| 4404 | 21 CFR 211.194(a)(1) | Sample identification and other information |
| 4576 | 21 CFR 211.192 | No written record of investigation |