Overview
- 4 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2011-05-31.
At a glance
Inspections
4
Form 483s
1
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 31 May 2011 | Not recorded | Clean | |
| 12 Aug 2010 | Not recorded | WL | View 483 → |
| 5 Aug 2002 | Not recorded | Clean | |
| 21 Jan 2000 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
12 Aug 2010
21 CFR 111.70(b)(1)
Specifications - component identity
Cited by Dhaval H Patel, Hitesh R Patel
12 Aug 2010
21 CFR 111.70(f)
Specifications - product received for packaging, labeling
Cited by Dhaval H Patel, Hitesh R Patel
12 Aug 2010
21 CFR 111.75(a)(2)(ii)(A)
Component - qualify supplier
Cited by Dhaval H Patel, Hitesh R Patel
12 Aug 2010
21 CFR 111.75(c)(1)
Specifications met - verify; production, process control
Cited by Dhaval H Patel, Hitesh R Patel
Investigators
FDA investigators tied to this site in the record.
Dhaval H Patel2 insp.
Hitesh R Patel1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.165(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.210(g) | 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(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(f) | 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)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.83(b)(3) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Soluble Products Co., LP's 1 Form 483
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