Overview
- 22 public-safe observations are available for this inspection.
- 10 structured CFR citations are represented.
- 4 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
2 Feb 2016
21 CFR 211.160(a)
Deviations from laboratory control requirements
Cited by Melissa T Roy, Nancy F Scheraga, Jose M Cayuela, Liatte Krueger
2 Feb 2016
21 CFR 211.160(a)
Deviations from laboratory control requirements
Cited by Melissa T Roy, Nancy F Scheraga, Jose M Cayuela, Liatte Krueger
2 Feb 2016
21 CFR 211.160(b)(3)
Acceptance of drug products
Cited by Melissa T Roy, Nancy F Scheraga, Jose M Cayuela, Liatte Krueger
2 Feb 2016
21 CFR 211.160(b)(3)
Acceptance of drug products
Cited by Melissa T Roy, Nancy F Scheraga, Jose M Cayuela, Liatte Krueger
2 Feb 2016
21 CFR 211.165(e)
Test methods
Cited by Melissa T Roy, Nancy F Scheraga, Jose M Cayuela, Liatte Krueger
Inspected site
ELElite Laboratories Inc.Northvale, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 314.80(c)(2) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b)(3) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 314.80(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 314.80(c)(1)(i) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 314.80(c)(1)(ii) | Cited across public-safe Form 483 observations | 2x |
Source document
PDF
PDF available
Form 483 source document
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Full 483 report
Get the verbatim text of all 22 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