Overview
- 17 public-safe observations are available for this inspection.
- 17 structured CFR citations are represented.
- 4 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
2 Jun 2011
21 CFR 111.70(e)
Specifications - identity, purity, strength, composition
Cited by Ileana Barreto-Pettit, Gabriel E Muniz, Teresa I Navas, German Rivera
2 Jun 2011
21 CFR 111.75(a)(2)(ii)(A)
Component - qualify supplier
Cited by Ileana Barreto-Pettit, Gabriel E Muniz, Teresa I Navas, German Rivera
2 Jun 2011
21 CFR 111.255(a)
Batch record - every batch
Cited by Ileana Barreto-Pettit, Gabriel E Muniz, Teresa I Navas, German Rivera
2 Jun 2011
21 CFR 111.415
Fill, assemble, package, label - quality
Cited by Ileana Barreto-Pettit, Gabriel E Muniz, Teresa I Navas, German Rivera
2 Jun 2011
21 CFR 111.455(a)
Hold - temperature, humidity, light
Cited by Ileana Barreto-Pettit, Gabriel E Muniz, Teresa I Navas, German Rivera
Inspected site
TPTarmac Products, Inc.Miami Gardens, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.255(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.415 | 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 111.75(a)(2)(ii)(A) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.125(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.137(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.142(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.150 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.170(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.184(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.196 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.204 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(a) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 17 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