FDA Inspection 1135635 — MCELROY IMPORTS
The FDA completed an inspection of MCELROY IMPORTS on February 9, 2021 in Glen Mills, PA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 13 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- February 9, 2021
- Fiscal Year
- 2021
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Glen Mills, PA (United States)
Additional Details
FSVP
Citations
| ID | CFR | Description |
|---|---|---|
| 18254 | 21 CFR 1.502(a) | Develop FSVP |
| 18263 | 21 CFR 1.504(b)(1) | Hazard analysis biological, chemical, physical |
| 18267 | 21 CFR 1.504(c)(1) | Evaluation absence of control |
| 18268 | 21 CFR 1.504(c)(1) | Evaluation severity |
| 18272 | 21 CFR 1.504(d) | Document review entity's hazard analysis |
| 18290 | 21 CFR 1.506(a)(1) | Approved supplier procedures - importer established |
| 18291 | 21 CFR 1.506(a)(1) | Unapproved supplier procedures - importer established |
| 18293 | 21 CFR 1.506(b) | Supplier verification - establish written procedures |
| 18296 | 21 CFR 1.506(d)(1)(i) | Verification activity frequency |
| 18297 | 21 CFR 1.506(d)(1)(i) | Verification activity - entity prevent hazard |
| 18301 | 21 CFR 1.506(d)(3) | Verification activity - another entity, assess |
| 18302 | 21 CFR 1.506(d)(3) | Verification activity - another entity, qualified individual |
| 18331 | 21 CFR 1.510(a)(2) | Record - sign, date |