Overview
- 8 public-safe observations are available for this inspection.
- 8 structured CFR citations are represented.
- 2 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
22 Jun 2011
21 CFR 110.40(a)
Food-contact - corrosion resistant
Cited by James R Montero, Ginger M Sykes
22 Jun 2011
21 CFR 111.12
Personnel - quality control personnel - qualified
Cited by James R Montero, Ginger M Sykes
22 Jun 2011
21 CFR 111.75(c)
Specifications met - verify; finished batch
Cited by James R Montero, Ginger M Sykes
22 Jun 2011
21 CFR 111.103
Written procedure quality control operations material review
Cited by James R Montero, Ginger M Sykes
Inspected site
TMTrace Minerals Opco LLCWest Haven, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 110.40(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.103 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.105(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.12 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.27(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.320(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.553 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(c) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 8 observations
Every observation in full, so your team sees exactly what was cited and how it was answered.
- The site's full inspection history around this Form 483
- Whether these citations escalated to a warning letter
- The investigators involved and the citations they repeat elsewhere