FDA Inspection 1132693 — Sirob Imports, Inc.
The FDA completed an inspection of Sirob Imports, Inc. on November 10, 2020 in Lindenhurst, NY. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 15 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- November 10, 2020
- Fiscal Year
- 2021
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Lindenhurst, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12744 | 21 CFR 120.8(b)(4) | HACCP plan - monitoring procedures - none listed |
| 12755 | 21 CFR 120.11(a)(1)(iv) | Records - not signed and dated by qualified individual |
| 18140 | 21 CFR 117.20(b) | Plant construction and design |
| 19030 | 21 CFR 117.130(a)(1) | Hazard Analysis - Identification of Hazard |
| 19036 | 21 CFR 117.145(a) | Process Controls Monitoring Procedures: Establish Implement |
| 19043 | 21 CFR 117.165(a)(4) | Process preventive controls - Record review |
| 21276 | 21 CFR 117.405(a)(1) | Supply-Chain Program Establish and Implement |
| 3071 | 21 CFR 114.80(a)(1) | Scheduled process |
| 3078 | 21 CFR 114.80(b) | Code - required elements |
| 3085 | 21 CFR 114.100(a) | Raw materials, packaging, finished product |
| 4470 | 21 CFR 108.25(c)(2) | Process filing |
| 9926 | 21 CFR 120.14(a) | Importer - written procedures |
| 9928 | 21 CFR 120.12(b) | Records - general - include name, date, time |
| 9929 | 21 CFR 120.12(b)(4) | Records - information not entered when observed |
| 9931 | 21 CFR 120.6(b) | Sanitation monitoring |