Overview
- 4 public-safe observations are available for this inspection.
- 4 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.
30 Jan 2013
21 CFR 111.60(a)
Production, in- process control system - design, quality
Cited by Rachel C Harrington, Nebil A Oumer
30 Jan 2013
21 CFR 111.75(d)(2)
Exempted, periodic testing; quality control
Cited by Rachel C Harrington, Nebil A Oumer
30 Jan 2013
21 CFR 111.140 (b)(3)(ii)
Material review, disposition, follow-up; investigation
Cited by Rachel C Harrington, Nebil A Oumer
30 Jan 2013
21 CFR 111.325(b)(2)(ii)
Records - document; results
Cited by Rachel C Harrington, Nebil A Oumer
Inspected site
TCTishcon CorporationSalisbury, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.140 (b)(3)(ii) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.325(b)(2)(ii) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.60(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(d)(2) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 4 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