Overview
- 9 public-safe observations are available for this inspection.
- 9 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.
25 Jan 2024
21 CFR 111.105(a)
Quality control - processes, specifications, written procedures
Cited by Jennifer A Robinson, Ciara J Bajulai Austin
25 Jan 2024
21 CFR 111.123(a)(1)
Quality control operations - master manufacturing record, modifications
Cited by Jennifer A Robinson, Ciara J Bajulai Austin
25 Jan 2024
21 CFR 111.123(a)(2)
Quality control operations - batch production records
Cited by Jennifer A Robinson, Ciara J Bajulai Austin
25 Jan 2024
21 CFR 111.123(b)(1)
Quality control - components, identity specifications
Cited by Jennifer A Robinson, Ciara J Bajulai Austin
25 Jan 2024
21 CFR 111.205(a)
Master manufacturing record - each batch
Cited by Jennifer A Robinson, Ciara J Bajulai Austin
Inspected site
ALAdept Life Sciences, LLCChandler, United States
Inspection team
CJCiara J Bajulai Austin
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.105(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.123(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.123(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.123(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.205(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.255(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(e) | 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, 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