Overview
- 8 public-safe observations are available for this inspection.
- 8 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.
29 Sep 2009
21 CFR 211.25(a)
Training--operations, GMPs, written procedures
Cited by Debra M Emerson, Stacey S Degarmo
29 Sep 2009
21 CFR 211.186(b)(8)
Description of containers, labels, et. al.
Cited by Debra M Emerson, Stacey S Degarmo
29 Sep 2009
21 CFR 314.80(b)
Failure to develop written procedures
Cited by Debra M Emerson, Stacey S Degarmo
29 Sep 2009
21 CFR 314.80(c)
Failure by applicant to report ADE
Cited by Debra M Emerson, Stacey S Degarmo
Inspected site
APArmstrong Pharmaceuticals, Inc.Canton, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.186(b)(8) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(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) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.80(c)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.81(b)(1)(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.81(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.81(b)(2)(i) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 8 observations
Every observation in full, 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