Overview
- 2 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2008-12-22.
At a glance
Inspections
2
Form 483s
1
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 22 Dec 2008 | Not recorded | 483 | View 483 → |
| 28 Mar 2008 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
22 Dec 2008
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Patsy J Domingo, Jonathan R Loving, Adam J Wilson
22 Dec 2008
21 CFR 211.130(e)
Packaging line inspection before use
Cited by Patsy J Domingo, Jonathan R Loving, Adam J Wilson
22 Dec 2008
21 CFR 211.182
Personnel dating/signing equipment log
Cited by Patsy J Domingo, Jonathan R Loving, Adam J Wilson
22 Dec 2008
21 CFR 211.182
Written records kept in individual logs
Cited by Patsy J Domingo, Jonathan R Loving, Adam J Wilson
22 Dec 2008
21 CFR 211.188
Prepared for each batch, include complete information
Cited by Patsy J Domingo, Jonathan R Loving, Adam J Wilson
Investigators
FDA investigators tied to this site in the record.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.182 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.130(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Caraco Pharmaceutical Laboratories, LTD.'s 1 Form 483
Source PDFs, verbatim observations, and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat