FDA Inspection 749225 — SEI Pharmaceuticals, Inc.
The FDA completed an inspection of SEI Pharmaceuticals, Inc. on September 29, 2011 in Miami, FL. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 25 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- September 29, 2011
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Unapproved and Misbranded Drugs
- Location
- Miami, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15382 | 21 CFR 111.8 | Written procedures - personnel qualifications |
| 15385 | 21 CFR 111.10(a)(2) | Personnel - health condition - supervisor notification |
| 15396 | 21 CFR 111.10(b)(6) | Hair restraints |
| 15401 | 21 CFR 111.12(b) | Personnel - quality control operations; identified |
| 15404 | 21 CFR 111.12(c) | Personnel - education, training, experience |
| 15429 | 21 CFR 111.15(k) | Sanitation supervisors - assigned |
| 15434 | 21 CFR 111.15(d)(2) | Pest control measures |
| 15452 | 21 CFR 111.15(f)(5) | Plumbing - backflow, cross connection |
| 15453 | 21 CFR 111.16 | Written procedures - cleaning |
| 15462 | 21 CFR 111.20(d)(1)(iv) | Physical plant - temperature, humidity controls |
| 15491 | 21 CFR 111.25 | Equipment - procedures |
| 15500 | 21 CFR 111.27(a)(2) | Equipment - design - no contamination |
| 15531 | 21 CFR 111.255(a) | Batch record - every batch |
| 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 |
| 15665 | 21 CFR 111.303 | Written procedures - tests, examinations; specifications met |
| 15736 | 21 CFR 111.353 | Manufacturing operations - written procedures |
| 15763 | 21 CFR 111.205(a) | Master manufacturing record - unique formulation |
| 15790 | 21 CFR 111.403 | Written procedures - labeling operations |
| 15791 | 21 CFR 111.403 | Written procedures -packaging operations |
| 15797 | 21 CFR 111.553 | Written procedures - product complaint |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |
| 16037 | 21 CFR 111.605 | Records - keep: 1 year, 2 years |
| 16042 | 21 CFR 111.503 | Written procedures - returned dietary supplement |