Overview
- 5 public-safe observations are available for this inspection.
- 5 structured CFR citations are represented.
- 4 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
5 May 2020
21 CFR 58.190(a)
Archives: data, documentation, specimens
Cited by Angela Shepas, Sunitha K Rajaram, Mark J Seaton, Lynda L Lanning
5 May 2020
21 CFR 58.35(b)(5)
QAU: authorize deviations from protocols or SOPs
Cited by Angela Shepas, Sunitha K Rajaram, Mark J Seaton, Lynda L Lanning
5 May 2020
21 CFR 58.35(b)(6)
QAU: review final study report
Cited by Angela Shepas, Sunitha K Rajaram, Mark J Seaton, Lynda L Lanning
5 May 2020
21 CFR 58.63(c)
Equipment: maintenance records
Cited by Angela Shepas, Sunitha K Rajaram, Mark J Seaton, Lynda L Lanning
5 May 2020
21 CFR 58.81(a)
SOPs: laboratory methods
Cited by Angela Shepas, Sunitha K Rajaram, Mark J Seaton, Lynda L Lanning
Inspected site
AAAlturas Analytics, Inc.Moscow, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 58.190(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.35(b)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.35(b)(6) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.63(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.81(a) | 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 5 observations
The source PDF, 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