Overview
- 9 public-safe observations are available for this inspection.
- 9 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.
2 Jun 2010
21 CFR 111.35(b)(2)
Document-equipment date of use, maintain, clean, sanitize
Cited by Eric Rothschild, Laishan L Lam, Liatte Krueger
2 Jun 2010
21 CFR 111.70(e)
Specifications - identity, purity, strength, composition
Cited by Eric Rothschild, Laishan L Lam, Liatte Krueger
2 Jun 2010
21 CFR 111.73
Specifications met - identity, purity, strength, composition
Cited by Eric Rothschild, Laishan L Lam, Liatte Krueger
2 Jun 2010
21 CFR 111.75(a)(2)(ii)(A)
Component - qualify supplier
Cited by Eric Rothschild, Laishan L Lam, Liatte Krueger
2 Jun 2010
21 CFR 111.75(c)(4)
Documentation - specifications met; basis, quality control
Cited by Eric Rothschild, Laishan L Lam, Liatte Krueger
Inspected site
TITriarco Industries, Inc.Paterson, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.210(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.255(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.35(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.455(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.73 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(a)(2)(ii)(A) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(c)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.83(b)(1) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 9 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