Overview
- 9 public-safe observations are available for this inspection.
- 9 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.
30 Sep 2022
21 CFR 211.110(a)
Written in-process control procedures
Cited by Patty P Kaewussdangkul, Margaret M Annes
30 Sep 2022
21 CFR 211.113(b)
Validation lacking for sterile drug products
Cited by Patty P Kaewussdangkul, Margaret M Annes
30 Sep 2022
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Patty P Kaewussdangkul, Margaret M Annes
30 Sep 2022
21 CFR 211.165(f)
Failing drug products not rejected
Cited by Patty P Kaewussdangkul, Margaret M Annes
30 Sep 2022
21 CFR 211.188
Prepared for each batch, include complete information
Cited by Patty P Kaewussdangkul, Margaret M Annes
Inspected site
QLQualgen, LLCEdmond, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.56(c) | Cited across public-safe Form 483 observations | 1x |
| FDCA 503B(a)(10) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 9 observations
The full inspection record, as Atlas holds it, 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