Overview
- 8 public-safe observations are available for this inspection.
- 8 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.
30 Nov 2016
21 CFR 58.130(a)
Conduct: in accordance with protocol
Cited by Anastasia I Offordile, Denise M Visco
30 Nov 2016
21 CFR 58.185(a)(10)
Final report: names of those involved
Cited by Anastasia I Offordile, Denise M Visco
30 Nov 2016
21 CFR 58.185(a)(5)
Final report: stability of test and control articles
Cited by Anastasia I Offordile, Denise M Visco
30 Nov 2016
21 CFR 58.31(d)
Management: testing of test and control articles
Cited by Anastasia I Offordile, Denise M Visco
Inspected site
LELabcorp Early Development Laboratories, Inc.Somerset, United States
Inspection team
DMDenise M Visco
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 58.113(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.130(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.185(a)(10) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.185(a)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.31(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.33(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.35(b)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.81(a) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 8 observations
The full inspection record, as Atlas holds it, 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