Overview
- 3 public-safe observations are available for this inspection.
- 2 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.
28 Dec 2021
21 CFR 211.160(a)
Following/documenting laboratory controls
Cited by Nicholas A Violand, Robin P Mathew
28 Dec 2021
21 CFR 211.160(a)
Lab controls established, including changes
Cited by Nicholas A Violand, Robin P Mathew
28 Dec 2021
21 CFR 211.22(a)
Authority lacking to review records, investigate errors
Cited by Nicholas A Violand, Robin P Mathew
Inspected site
ESEuTech Scientific Services, Inc.Budd Lake, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(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 3 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