FDA Inspection 1086513 — BMF, Inc.
The FDA completed an inspection of BMF, Inc. on April 17, 2019 in Caguas, PR. 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
- April 17, 2019
- Fiscal Year
- 2019
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Caguas, PR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12709 | 21 CFR 129.80(c) | Records - cleaning, sanitizing solutions |
| 12725 | 21 CFR 129.80(b)(1) | Mechanical washers - inspection |
| 1401 | 21 CFR 129.37(a) | Product water-contact surfaces - inspection |
| 1417 | 21 CFR 129.37(c) | Single-service container, cap, seal-exam, sanitize, handle |
| 1453 | 21 CFR 129.40(a)(1) | Suitability - equipment, utensils |
| 16499 | 21 CFR 129.35(a)(3)(i) | Coliforms - follow up testing |
| 16501 | 21 CFR 129.35(a)(4)(i) | Public water system test results, certificates |
| 16504 | 21 CFR 129.35(b) | Air - contact surface - oil, dust, rust, moisture |
| 1761 | 21 CFR 129.80(a) | Records - equipment inspection |
| 18138 | 21 CFR 117.10 | Personnel |
| 18139 | 21 CFR 117.20(a) | Grounds |
| 18151 | 21 CFR 117.40(f) | Instruments and Controls |
| 2274 | 21 CFR 129.80(g)(1) | Bacteriological test - bottled water |
| 2275 | 21 CFR 129.80(g)(2) | Chemical, physical, radiological tests - bottled water |
| 2283 | 21 CFR 129.80(f) | Performance monitoring - filler, capper, sealer |