Overview
- 10 public-safe observations are available for this inspection.
- 10 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.
27 Mar 2014
21 CFR 820.20(c)
Management review - Lack of or inadequate procedures
Cited by Erin M Miller, Bleta Vuniqi
27 Mar 2014
21 CFR 820.22
Quality audits - Lack of or inadequate procedures
Cited by Erin M Miller, Bleta Vuniqi
27 Mar 2014
21 CFR 820.50
Purchasing controls, Lack of or inadequate procedures
Cited by Erin M Miller, Bleta Vuniqi
27 Mar 2014
21 CFR 820.70(a)
Process control procedures, Lack of or inadequate procedures
Cited by Erin M Miller, Bleta Vuniqi
27 Mar 2014
21 CFR 820.72(a)
Calibration, Inspection, etc. Procedures Lack of or Inadequ
Cited by Erin M Miller, Bleta Vuniqi
Inspected site
HIHaven Innovation, Inc.Grand Haven, United States
Inspection team
EMErin M Miller
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.181 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.20(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.22 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.72(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(a) | Cited across public-safe Form 483 observations | 1x |
Source document
PDF
PDF available
Form 483 source document
The source document is available to authorized Atlas users.
Full 483 report
Get the verbatim text of all 10 observations
The source PDF and 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