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.
8 Aug 2025
21 CFR 111.15(b)
Physical plant - clean and sanitary
Cited by Karen A Spencer, Siobhan G Taylor, Timothy A Tennell
8 Aug 2025
21 CFR 111.260
Batch record - required information
Cited by Karen A Spencer, Siobhan G Taylor, Timothy A Tennell
8 Aug 2025
21 CFR 111.27(a)
Equipment - design - appropriate and suitable
Cited by Karen A Spencer, Siobhan G Taylor, Timothy A Tennell
8 Aug 2025
21 CFR 111.365(a)
Conditions, controls -protect; microorganisms, contamination
Cited by Karen A Spencer, Siobhan G Taylor, Timothy A Tennell
8 Aug 2025
21 CFR 111.455(c)
Hold - mix-up, contamination, deterioration
Cited by Karen A Spencer, Siobhan G Taylor, Timothy A Tennell
Inspected site
TCTishcon CorporationSalisbury, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.15(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.260 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.27(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.365(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.455(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(e) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 7 observations
The full inspection record, as Atlas holds it, 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