Overview
- 12 public-safe observations are available for this inspection.
- 6 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.
3 Aug 2018
21 CFR 111.103
Written procedures - quality control operations
Cited by Aqualia L Nelson, Alesya V Oleynik, Kathleen J Close
3 Aug 2018
21 CFR 111.103
Written procedures - quality control operations
Cited by Aqualia L Nelson, Alesya V Oleynik, Kathleen J Close
3 Aug 2018
21 CFR 111.205(a)
Master manufacturing record - unique formulation
Cited by Aqualia L Nelson, Alesya V Oleynik, Kathleen J Close
3 Aug 2018
21 CFR 111.205(a)
Master manufacturing record - unique formulation
Cited by Aqualia L Nelson, Alesya V Oleynik, Kathleen J Close
3 Aug 2018
21 CFR 111.255(a)
Batch record - every batch
Cited by Aqualia L Nelson, Alesya V Oleynik, Kathleen J Close
Inspected site
ZLZakah Life LLCAnkeny, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.103 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.205(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.255(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.353 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.453 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.70(e) | Cited across public-safe Form 483 observations | 2x |
Full 483 report
Get the verbatim text of all 12 observations
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