Overview
- 5 public-safe observations are available for this inspection.
- 5 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.
18 Feb 2011
21 CFR 111.35(b)(2)
Document-equipment date of use, maintain, clean, sanitize
Cited by Kwong P Lee, Pasquale L Leone, Melinda Ruiz
18 Feb 2011
21 CFR 111.260(l)(3)
Batch record - approved, released, rejected; batch
Cited by Kwong P Lee, Pasquale L Leone, Melinda Ruiz
18 Feb 2011
21 CFR 111.353
Manufacturing operations - written procedures
Cited by Kwong P Lee, Pasquale L Leone, Melinda Ruiz
18 Feb 2011
21 CFR 111.370
Rejected dietary supplements - identify, hold, control
Cited by Kwong P Lee, Pasquale L Leone, Melinda Ruiz
18 Feb 2011
21 CFR 111.553
Written procedures - product complaint
Cited by Kwong P Lee, Pasquale L Leone, Melinda Ruiz
Inspected site
VIVita-Nat, Inc.Farmingdale, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.260(l)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.35(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.353 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.370 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.553 | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 5 observations
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