Overview
- 10 public-safe observations are available for this inspection.
- 10 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.
9 Nov 2009
21 CFR 211.115(a)
Reprocessing procedures lack steps to be taken
Cited by Matthew R Noonan, Michael J Nerz, Jeen S Min
9 Nov 2009
21 CFR 211.192
Quality control unit review of records
Cited by Matthew R Noonan, Michael J Nerz, Jeen S Min
9 Nov 2009
21 CFR 820.20(c)
Management review - Lack of or inadequate procedures
Cited by Matthew R Noonan, Michael J Nerz, Jeen S Min
9 Nov 2009
21 CFR 820.30(g)
Design Validation - Risk analysis not performed/inadequate
Cited by Matthew R Noonan, Michael J Nerz, Jeen S Min
9 Nov 2009
21 CFR 820.50
Purchasing controls, Lack of or inadequate procedures
Cited by Matthew R Noonan, Michael J Nerz, Jeen S Min
Inspected site
MCMedical Components, Inc dba MedCompHarleysville, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.115(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.20(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(d) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 10 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