FDA Inspection 701774 — Reckitt Benckiser, Inc.
The FDA completed an inspection of Reckitt Benckiser, Inc. on January 5, 2011 in Fort Worth, TX. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 14 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- January 5, 2011
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Fort Worth, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1079 | 21 CFR 211.22(a) | Contract drug products--lack of responsibility |
| 1098 | 21 CFR 211.22(c) | Approve or reject procedures or specs |
| 1162 | 21 CFR 211.28(a) | Protective Apparel Not Worn |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1801 | 21 CFR 211.84(a) | Components withheld from use pending release |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3559 | 21 CFR 211.56(a) | Sanitation--buildings not clean, free of infestation |
| 3565 | 21 CFR 211.58 | Buildings not maintained in good state of repair |
| 3570 | 21 CFR 211.100(a) | Approval and review of procedures |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 3592 | 21 CFR 211.110(c) | In-process materials characteristics testing |
| 4409 | 21 CFR 211.194(a)(4) | Data secured in course of each test |