Overview
- 12 public-safe observations are available for this inspection.
- 12 structured CFR citations are represented.
- 5 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
Quality control - processes, specifications, written procedures
Cited by Dariusz Galezowski, Pablo Alcantara, Chase S Baldwin, Siobhan G Taylor, Roshni J Patel
Quality control operations - master manufacturing record, modifications
Cited by Dariusz Galezowski, Pablo Alcantara, Chase S Baldwin, Siobhan G Taylor, Roshni J Patel
Master manufacturing record - each batch
Cited by Dariusz Galezowski, Pablo Alcantara, Chase S Baldwin, Siobhan G Taylor, Roshni J Patel
Batch record - component; identity, weight
Cited by Dariusz Galezowski, Pablo Alcantara, Chase S Baldwin, Siobhan G Taylor, Roshni J Patel
Batch record - performance
Cited by Dariusz Galezowski, Pablo Alcantara, Chase S Baldwin, Siobhan G Taylor, Roshni J Patel
Inspected site
Inspection team
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 111.205(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.260(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.260(m) | 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(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(h) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(h)(2) | Cited across public-safe Form 483 observations | 1x |
Source document
Form 483 source document
The source document is available to authorized Atlas users.
Full 483 report
Get the verbatim text of all 12 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