Overview
- 4 public-safe observations are available for this inspection.
- 4 structured CFR citations are represented.
- 1 investigator is tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
3 Feb 2012
21 CFR 820.70(a)
Process control procedures, Lack of or inadequate procedures
Cited by Laurie B Frazier
3 Feb 2012
21 CFR 820.75(b)(2)
Documentation of validated process performance
Cited by Laurie B Frazier
3 Feb 2012
21 CFR 820.75(c)
Documentation - review in response to changes or deviations
Cited by Laurie B Frazier
Inspected site
MLMICROspecialties, LLCMiddletown, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.70(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(c) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 4 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