Overview
- 8 public-safe observations are available for this inspection.
- 8 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.
6 Oct 2010
21 CFR 820.22
Quality audits - Lack of or inadequate procedures
Cited by Richard J Tucker, Melissa J Holz
6 Oct 2010
21 CFR 820.30(h)
Design transfer - Lack of or inadequate procedures
Cited by Richard J Tucker, Melissa J Holz
6 Oct 2010
21 CFR 820.80(b)
Lack of or inadequate receiving acceptance procedures
Cited by Richard J Tucker, Melissa J Holz
6 Oct 2010
21 CFR 820.80(d)
Lack of or inadequate final acceptance procedures
Cited by Richard J Tucker, Melissa J Holz
6 Oct 2010
21 CFR 820.90(b)(1)
Procedures for product review,disposition lack of/inadequate
Cited by Richard J Tucker, Melissa J Holz
Inspected site
TITreyMed, Inc.Sussex, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.181 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.22 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(h) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.90(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.90(b)(2) | 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 8 observations
The source PDF and 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