Overview
- 6 public-safe observations are available for this inspection.
- 5 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.
10 Jun 2022
21 CFR 211.100(a)
Approval and review of procedures
Cited by Patty P Kaewussdangkul, Steven A Brettler
10 Jun 2022
21 CFR 211.137(a)
Expiration date lacking
Cited by Patty P Kaewussdangkul, Steven A Brettler
10 Jun 2022
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Patty P Kaewussdangkul, Steven A Brettler
10 Jun 2022
21 CFR 211.165(a)
Testing and release for distribution
Cited by Patty P Kaewussdangkul, Steven A Brettler
10 Jun 2022
FDCA 503B(a)(10)
Container label, outsourcer facility
Cited by Patty P Kaewussdangkul, Steven A Brettler
Inspected site
FOFARMAKEIO OUTSOURCING LLCSouthlake, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| FDCA 503B(a)(10) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.137(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(a) | Cited across public-safe Form 483 observations | 1x |
Source document
PDF
PDF available
Form 483 source document
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Full 483 report
Get the verbatim text of all 6 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