Overview
- 6 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.
9 Mar 2009
21 CFR 211.67(b)(5)
Cleaning SOPs/equipment protection
Cited by Thomas R Berry, Hai Lien T Phung
9 Mar 2009
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Thomas R Berry, Hai Lien T Phung
9 Mar 2009
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Thomas R Berry, Hai Lien T Phung
9 Mar 2009
21 CFR 211.198(b)(2)
Complaint Investigation/Follow-Up Findings
Cited by Thomas R Berry, Hai Lien T Phung
Inspected site
MLMikart, LLCAtlanta, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.80(b) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 6 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