Overview
- 6 public-safe observations are available for this inspection.
- 6 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.
6 Feb 2026
21 CFR 211.110(c)
In-process materials characteristics testing
Cited by Brandy N Lepage, Victoria Spivak
6 Feb 2026
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Brandy N Lepage, Victoria Spivak
6 Feb 2026
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Brandy N Lepage, Victoria Spivak
6 Feb 2026
21 CFR 211.42(c)(10)(iv)
Environmental Monitoring System
Cited by Brandy N Lepage, Victoria Spivak
Inspected site
ACAlcami Carolinas CorporationCharleston, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.110(c) | 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 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 6 observations
The full inspection record, as Atlas holds it, 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