Overview
- 12 public-safe observations are available for this inspection.
- 6 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 Jul 2017
21 CFR 58.130(e)
Conduct: changes not obscuring original entries
Cited by Zhou Chen, Mark J Seaton, Matthew C Watson
21 Jul 2017
21 CFR 58.29(a)
Personnel: education, training, experience
Cited by Zhou Chen, Mark J Seaton, Matthew C Watson
21 Jul 2017
21 CFR 58.33(b)
Study director: all data recorded and verified
Cited by Zhou Chen, Mark J Seaton, Matthew C Watson
21 Jul 2017
21 CFR 58.33(c)
Study director: unforeseen circumstances
Cited by Zhou Chen, Mark J Seaton, Matthew C Watson
21 Jul 2017
21 CFR 58.35(b)(5)
QAU: authorize deviations from protocols or SOPs
Cited by Zhou Chen, Mark J Seaton, Matthew C Watson
Inspected site
LBLabcorp Bedford LLC.Bedford, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 58.130(e) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 58.29(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 58.33(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 58.33(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 58.35(b)(5) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 58.35(b)(7) | Cited across public-safe Form 483 observations | 2x |
Full 483 report
Get the verbatim text of all 12 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