Overview
- 8 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.
9 Apr 2019
21 CFR 211.110(b)
In-process conformity - examination, sample testing
Cited by Christina K Theodorou, Lisa B Orr, Dandan Wang
9 Apr 2019
21 CFR 211.113(a)
Procedures for non-sterile drug products
Cited by Christina K Theodorou, Lisa B Orr, Dandan Wang
9 Apr 2019
21 CFR 211.160(b)(3)
Acceptance of drug products
Cited by Christina K Theodorou, Lisa B Orr, Dandan Wang
9 Apr 2019
21 CFR 211.192
Extent of discrepancy, failure investigations
Cited by Christina K Theodorou, Lisa B Orr, Dandan Wang
9 Apr 2019
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Christina K Theodorou, Lisa B Orr, Dandan Wang
Inspected site
APApozeal Pharmaceuticals Inc.Levittown, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.110(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.113(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | 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)(3) | 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