Overview
- 8 public-safe observations are available for this inspection.
- 8 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.
5 Sep 2014
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Derek S Dealy, Craig D Zagata, Matthew R Noonan
5 Sep 2014
21 CFR 211.25(a)
Training--operations, GMPs, written procedures
Cited by Derek S Dealy, Craig D Zagata, Matthew R Noonan
5 Sep 2014
21 CFR 211.67(c)
Cleaning/maintenance records not kept
Cited by Derek S Dealy, Craig D Zagata, Matthew R Noonan
5 Sep 2014
21 CFR 211.84(d)(2)
Reports of Analysis (Components)
Cited by Derek S Dealy, Craig D Zagata, Matthew R Noonan
5 Sep 2014
21 CFR 211.84(e)
Rejecting When Specifications Not Met
Cited by Derek S Dealy, Craig D Zagata, Matthew R Noonan
Inspected site
HCHigh Chemical Company, Div of National Generic DistributorsLevittown, 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 | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(e) | 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 8 observations
The source PDF and 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