Overview
- 8 public-safe observations are available for this inspection.
- 8 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.
1 Mar 2024
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Robert J Ham, Kevin P Regan, Melissa M Steiger
1 Mar 2024
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Robert J Ham, Kevin P Regan, Melissa M Steiger
1 Mar 2024
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Robert J Ham, Kevin P Regan, Melissa M Steiger
1 Mar 2024
21 CFR 211.22(c)
Approve or reject procedures or specs
Cited by Robert J Ham, Kevin P Regan, Melissa M Steiger
1 Mar 2024
21 CFR 211.42(c)
Defined areas of adequate size for operations
Cited by Robert J Ham, Kevin P Regan, Melissa M Steiger
Inspected site
ICIntegraDose Compounding Services LLCShoreview, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(v) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(vi) | Cited across public-safe Form 483 observations | 1x |
| FDCA 503B(b)(2)(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 8 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