FDA Inspection 1230818 — LS Promotions Inc.
The FDA completed an inspection of LS Promotions Inc. on May 2, 2024 in Ronkonkoma, NY. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 11 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- May 2, 2024
- Fiscal Year
- 2024
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Ronkonkoma, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1098 | 21 CFR 211.22(c) | Approve or reject procedures or specs |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1395 | 21 CFR 211.103 | Actual vs. theoretical yields not determined |
| 1448 | 21 CFR 211.111 | Establishment of time limitations |
| 1540 | 21 CFR 211.125(a) | Strict control not exercised over labeling issued |
| 1833 | 21 CFR 211.84(d)(1) | Identity Testing of Each Component |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 2020 | 21 CFR 211.188(b)(8) | Labeling Control Records and Label Copies |
| 4342 | 21 CFR 211.142(b) | Storage under appropriate conditions |
| 4374 | 21 CFR 211.188(b)(6) | Inspection of packaging and labeling area |