Overview
- 72 public-safe observations are available for this inspection.
- 11 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.
14 Mar 2019
21 CFR 111.105(g)
Quality control - reserve samples
Cited by Marinee Flores-Marrero, Lissette Paiz, Rozelle G Smith
14 Mar 2019
21 CFR 111.105(g)
Quality control - reserve samples
Cited by Marinee Flores-Marrero, Lissette Paiz, Rozelle G Smith
14 Mar 2019
21 CFR 111.105(g)
Quality control - reserve samples
Cited by Marinee Flores-Marrero, Lissette Paiz, Rozelle G Smith
14 Mar 2019
21 CFR 111.123(a)(5)
Quality control operations - reprocessing
Cited by Marinee Flores-Marrero, Lissette Paiz, Rozelle G Smith
14 Mar 2019
21 CFR 111.123(a)(5)
Quality control operations - reprocessing
Cited by Marinee Flores-Marrero, Lissette Paiz, Rozelle G Smith
Inspected site
ISInnova SoftGel LLCMiami, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 12x |
| 21 CFR 111.105(g) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 111.123(a)(5) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 111.27(a)(2) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 111.320(a) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 111.365(a) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 111.365(i) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 211.165(b) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 6x |
Source document
PDF
PDF available
Form 483 source document
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Full 483 report
Get the verbatim text of all 72 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