Overview
- 8 public-safe observations are available for this inspection.
- 8 structured CFR citations are represented.
- 3 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
30 Jun 2017
21 CFR 111.113(a)(3)
Quality control - adulteration; material review, disposition
Cited by Gianine E Tompkins, Melissa B Libby, Gianine E Delade
30 Jun 2017
21 CFR 111.113(b)(2)
Quality control - reject; specification not met
Cited by Gianine E Tompkins, Melissa B Libby, Gianine E Delade
30 Jun 2017
21 CFR 111.123(a)(2)
Quality control operations - batch production records
Cited by Gianine E Tompkins, Melissa B Libby, Gianine E Delade
30 Jun 2017
21 CFR 111.127(c)
Quality control operations - packaging, labeling; records
Cited by Gianine E Tompkins, Melissa B Libby, Gianine E Delade
30 Jun 2017
21 CFR 111.70(b)(1)
Specifications - component identity
Cited by Gianine E Tompkins, Melissa B Libby, Gianine E Delade
Inspected site
MHMaximum Human Performance, LLCWest Caldwell, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.113(a)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.113(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.123(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.127(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(a)(2) | 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