Overview
- 6 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.
7 Jul 2025
21 CFR 211.122(a)
Sampling/testing of labeling/packaging materials
Cited by Ronda R Loyd Jones, Mickell Smith, Michael Z Weigman
7 Jul 2025
21 CFR 211.165(a)
Testing and release for distribution
Cited by Ronda R Loyd Jones, Mickell Smith, Michael Z Weigman
7 Jul 2025
21 CFR 211.166(a)
Lack of written stability program
Cited by Ronda R Loyd Jones, Mickell Smith, Michael Z Weigman
7 Jul 2025
21 CFR 211.198(a)
Complaint Handling Procedure
Cited by Ronda R Loyd Jones, Mickell Smith, Michael Z Weigman
7 Jul 2025
21 CFR 211.22(a)
Contract drug products--lack of responsibility
Cited by Ronda R Loyd Jones, Mickell Smith, Michael Z Weigman
Inspected site
CTCosMedical Technologies, LLCDavie, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.122(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a) | 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(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | 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 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