FDA Inspection 818127 — SEI Pharmaceuticals, Inc.
The FDA completed an inspection of SEI Pharmaceuticals, Inc. on February 6, 2013 in Miami, FL. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 21 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- February 6, 2013
- Fiscal Year
- 2013
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Miami, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15382 | 21 CFR 111.8 | Written procedures - personnel qualifications |
| 15404 | 21 CFR 111.12(c) | Personnel - education, training, experience |
| 15434 | 21 CFR 111.15(d)(2) | Pest control measures |
| 15453 | 21 CFR 111.16 | Written procedures - cleaning |
| 15491 | 21 CFR 111.25 | Equipment - procedures |
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15573 | 21 CFR 111.153 | Written procedures - product received; packaging, labeling |
| 15575 | 21 CFR 111.153 | Written procedures - rejected products |
| 15641 | 21 CFR 111.453 | Written procedures - holding |
| 15736 | 21 CFR 111.353 | Manufacturing operations - written procedures |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15790 | 21 CFR 111.403 | Written procedures - labeling operations |
| 15791 | 21 CFR 111.403 | Written procedures -packaging operations |
| 15796 | 21 CFR 111.430(b) | Records - packaging, labeling operations |
| 15797 | 21 CFR 111.553 | Written procedures - product complaint |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15861 | 21 CFR 111.75(a)(2)(ii)(A) | Component - qualify supplier |
| 15869 | 21 CFR 111.75(c) | Specifications met - verify; finished batch |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |
| 16037 | 21 CFR 111.605 | Records - keep: 1 year, 2 years |
| 16083 | 21 CFR 111.35(b)(6) | Documentation - equipment functions; intended use |