654857
Absolute Natural Blenders, Inc. — FEI 1000208724
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- April 9, 2010
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Melbourne, FL (United States)
Citations
| ID | CFR | Description |
|---|
| 1079 | 21 CFR 211.22(a) | Contract drug products--lack of responsibility |
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1163 | 21 CFR 211.28(b) | Habits of good sanitation & health |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1270 | 21 CFR 211.68(b) | input/output verification |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1411 | 21 CFR 211.105(b) | Distinctive ID or code not recorded in batch record |
| 1540 | 21 CFR 211.125(a) | Strict control not exercised over labeling issued |
| 1728 | 21 CFR 211.87 | Retest of approved components/containers/closures |
| 1810 | 21 CFR 211.160(a) | Lab controls established, including changes |
| 1833 | 21 CFR 211.84(d)(1) | Identity Testing of Each Component |
| 1886 | 21 CFR 211.165(c) | Sampling and testing plans not described |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 1942 | 21 CFR 211.180(e) | Records reviewed annually |
| 2402 | 21 CFR 211.194(a)(5) | Testing Calculations |
| 2567 | 21 CFR 211.198(a) | Adverse Drug Experience |
| 3562 | 21 CFR 211.56(c) | Written procedures lacking for use of pesticides etc. |
| 3602 | 21 CFR 211.160(a) | Deviations from laboratory control requirements |
| 3616 | 21 CFR 211.165(d) | Acceptance criteria for sampling & testing |
| 3632 | 21 CFR 211.170(b) | Annual visual exams of drug products |
| 4303 | 21 CFR 211.67(b) | Written procedures fail to include |
| 4353 | 21 CFR 211.160(b)(4) | Instruments, apparatus, et. al. not meeting specs |
| 4373 | 21 CFR 211.188(b)(7) | Actual yield, % of theoretical yield |
| 4413 | 21 CFR 211.194(a)(8) | Second person sign off |