Overview
- 9 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.
6 Oct 2014
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Jessica L Pressley, Ileana Barreto-Pettit, Miguel A Martinez
6 Oct 2014
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Jessica L Pressley, Ileana Barreto-Pettit, Miguel A Martinez
6 Oct 2014
21 CFR 211.166(a)
Written program not followed
Cited by Jessica L Pressley, Ileana Barreto-Pettit, Miguel A Martinez
6 Oct 2014
21 CFR 211.166(a)(2)
Stability sample storage conditions described
Cited by Jessica L Pressley, Ileana Barreto-Pettit, Miguel A Martinez
6 Oct 2014
21 CFR 211.166(a)(3)
Valid stability test methods
Cited by Jessica L Pressley, Ileana Barreto-Pettit, Miguel A Martinez
Inspected site
HDHill Dermaceuticals, Inc.Sanford, 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 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.81(b)(1)(ii) | 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 9 observations
The source PDF and 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