Overview
- 3 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-02-23.
At a glance
Inspections
3
Form 483s
2
EIRs
1
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 21 Feb 2024 – 23 Feb 2024 | Human Drugs | Clean | |
| 10 Jun 2022 – 17 Jun 2022 | Human Drugs | 483 | View 483 → |
| 17 Sep 2019 – 19 Sep 2019 | Human Drugs | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
17 Jun 2022
21 CFR 314.80(b)
Failure to develop written procedures
Cited by Jeanne J Thai, Yuanyuan Li, Colleen E Burke
17 Jun 2022
21 CFR 314.80(c)(2)
Late submission of annual safety reports
Cited by Jeanne J Thai, Yuanyuan Li, Colleen E Burke
17 Jun 2022
21 CFR 314.80(j)
Failure to maintain records
Cited by Jeanne J Thai, Yuanyuan Li, Colleen E Burke
19 Sep 2019
21 CFR 211.22(a)
Contract drug products--lack of responsibility
Cited by Alan M Roberts, Peng Zhou
Investigators
FDA investigators tied to this site in the record.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.22(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.80(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.80(c)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.80(j) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.81(b)(2) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind AltaThera Pharmaceuticals LLC's 2 Form 483s
Source PDFs, verbatim observations, and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat