Overview
- 7 public-safe observations are available for this inspection.
- 6 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.
11 Aug 2022
21 CFR 211.160(b)(4)
Calibration - at intervals, written program, remedial action
Cited by Saleem A Akhtar, Ankur C Patel
11 Aug 2022
21 CFR 211.166(a)
Results not used for expiration dates, storage cond.
Cited by Saleem A Akhtar, Ankur C Patel
11 Aug 2022
21 CFR 211.188(b)
Batch production and Batch Control Record Requirements
Cited by Saleem A Akhtar, Ankur C Patel
11 Aug 2022
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Saleem A Akhtar, Ankur C Patel
Inspected site
LGLinde Gas & Equipment Inc.Phillipsburg, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | 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 7 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