Overview
- 9 public-safe observations are available for this inspection.
- 9 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.
21 Aug 2014
21 CFR 820.25(b)
Training - Lack of or inadequate procedures
Cited by Frank J Marciniak, Dhaval H Patel, Xiaoping Guan
21 Aug 2014
21 CFR 820.70(c)
Environmental control Lack of or inadequate procedures
Cited by Frank J Marciniak, Dhaval H Patel, Xiaoping Guan
21 Aug 2014
21 CFR 820.70(d)
Personnel requirements, Lack of or inadequate requirements
Cited by Frank J Marciniak, Dhaval H Patel, Xiaoping Guan
21 Aug 2014
21 CFR 820.75(a)
Lack of or inadequate process validation
Cited by Frank J Marciniak, Dhaval H Patel, Xiaoping Guan
21 Aug 2014
21 CFR 820.80(d)
Lack of or inadequate final acceptance procedures
Cited by Frank J Marciniak, Dhaval H Patel, Xiaoping Guan
Inspected site
EMExcelsior Medical LLCNeptune, United States
Inspection team
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 820.140 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.180(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.184 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.25(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(d) | 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(d) | 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 9 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