Overview
- 3 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2013-07-17.
At a glance
Inspections
3
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 9 Jul 2013 – 17 Jul 2013 | Foods & Cosmetics | 483 | View 483 → |
| 18 Mar 2013 – 22 Mar 2013 | Foods & Cosmetics | 483 | View 483 → |
| 23 Mar 2012 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
17 Jul 2013
21 CFR 111.30(a)
Equipment - automated - design, selection
Cited by Joy P Matthias, Sarah A Meehan
17 Jul 2013
21 CFR 111.75(a)(1)(i)
Component - verify identity, dietary ingredient
Cited by Joy P Matthias, Sarah A Meehan
17 Jul 2013
21 CFR 111.75(a)(2)(ii)(A)
Component - qualify supplier
Cited by Joy P Matthias, Sarah A Meehan
17 Jul 2013
21 CFR 111.75(b)(1)
Specifications met, in-process - quality finished batch
Cited by Joy P Matthias, Sarah A Meehan
17 Jul 2013
21 CFR 111.75(c)
Specifications met - verify; finished batch
Cited by Joy P Matthias, Sarah A Meehan
Investigators
FDA investigators tied to this site in the record.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.105 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.255(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.255(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.30(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.455(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.75(a)(1)(i) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.75(a)(2)(ii)(A) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.75(b)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.75(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.87 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Mira Health Products Ltd.'s 3 Form 483s
Verbatim observations and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat