Overview
- 7 public-safe observations are available for this inspection.
- 7 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.
9 Nov 2023
21 CFR 111.103
Written procedures - quality control operations
Cited by Mohamad A Chahine, Osama M Hamoud, Karen A Spencer
9 Nov 2023
21 CFR 111.255(b)
Batch record - complete
Cited by Mohamad A Chahine, Osama M Hamoud, Karen A Spencer
9 Nov 2023
21 CFR 111.27(b)
Instruments - calibration
Cited by Mohamad A Chahine, Osama M Hamoud, Karen A Spencer
9 Nov 2023
21 CFR 111.70(b)(1)
Specifications - component identity
Cited by Mohamad A Chahine, Osama M Hamoud, Karen A Spencer
9 Nov 2023
21 CFR 111.70(b)(2)
Specifications-component purity, strength, composition
Cited by Mohamad A Chahine, Osama M Hamoud, Karen A Spencer
Inspected site
ITImagilin Technology LlcFrederick, 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 | 1x |
| 21 CFR 111.255(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.27(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(a)(1)(i) | 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 7 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