Overview
- 9 public-safe observations are available for this inspection.
- 9 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 Mar 2013
21 CFR 111.30(a)
Equipment - automated - design, selection
Cited by Sarah A Meehan, Ann M Stewart
22 Mar 2013
21 CFR 111.75(a)(1)(i)
Component - verify identity, dietary ingredient
Cited by Sarah A Meehan, Ann M Stewart
22 Mar 2013
21 CFR 111.75(a)(2)(ii)(A)
Component - qualify supplier
Cited by Sarah A Meehan, Ann M Stewart
22 Mar 2013
21 CFR 111.75(b)(1)
Specifications met, in-process - quality finished batch
Cited by Sarah A Meehan, Ann M Stewart
22 Mar 2013
21 CFR 111.75(c)
Specifications met - verify; finished batch
Cited by Sarah A Meehan, Ann M Stewart
Inspected site
MHMira Health Products Ltd.Farmingdale, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.105 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.255(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.255(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.30(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.455(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(a)(1)(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(a)(2)(ii)(A) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(b)(1) | 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 9 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