Overview
- 7 public-safe observations are available for this inspection.
- 7 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.
6 Sep 2024
21 CFR 211.113(b)
Validation lacking for sterile drug products
Cited by Tekalign Wondimu, Yaharn Su, Kara J Wright
6 Sep 2024
21 CFR 211.180(c)
Records not made readily available to FDA
Cited by Tekalign Wondimu, Yaharn Su, Kara J Wright
6 Sep 2024
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Tekalign Wondimu, Yaharn Su, Kara J Wright
6 Sep 2024
21 CFR 211.42(c)(10)(iv)
Environmental Monitoring System
Cited by Tekalign Wondimu, Yaharn Su, Kara J Wright
6 Sep 2024
21 CFR 211.80(a)
Procedures To Be in Writing
Cited by Tekalign Wondimu, Yaharn Su, Kara J Wright
Inspected site
APAnnovex Pharma, Inc.Lorton, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(c) | 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 211.80(a) | Cited across public-safe Form 483 observations | 1x |
| FDCA 503B(a)(10)(A) | 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 7 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