Overview
- 11 public-safe observations are available for this inspection.
- 11 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 Mar 2014
21 CFR 111.12(b)
Personnel - quality control operations
Cited by Ashley N Williams, Jamie M Bumpas
6 Mar 2014
21 CFR 111.55
Production, process controls - implement
Cited by Ashley N Williams, Jamie M Bumpas
6 Mar 2014
21 CFR 111.70(b)(1)
Specifications - component identity
Cited by Ashley N Williams, Jamie M Bumpas
6 Mar 2014
21 CFR 111.70(e)
Specifications - identity, purity, strength, composition
Cited by Ashley N Williams, Jamie M Bumpas
6 Mar 2014
21 CFR 111.70(g)
Specifications - finished packaging, labeling
Cited by Ashley N Williams, Jamie M Bumpas
Inspected site
DDDr. Dennis BlackSpringville, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.103 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.105(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.12(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.255(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.535(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.55 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.570(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(g) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.83(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 11 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