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.
31 Mar 2011
21 CFR 806.20(b)(4)
Justification for not reporting
Cited by Marilyn Santiago, Shelly A Rios Laluz
31 Mar 2011
21 CFR 820.70(a)
Process control procedures, Lack of or inadequate procedures
Cited by Marilyn Santiago, Shelly A Rios Laluz
31 Mar 2011
21 CFR 820.100(a)
Lack of or inadequate procedures
Cited by Marilyn Santiago, Shelly A Rios Laluz
31 Mar 2011
21 CFR 820.198(a)
Lack of or inadequate complaint procedures
Cited by Marilyn Santiago, Shelly A Rios Laluz
Inspected site
BDBecton Dickinson Caribe LtdSan Lorenzo, United States
Inspection team
SAShelly A Rios Laluz
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 806.20(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(a) | 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