Overview
- 10 FDA inspections are on record.
- 7 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-05-05.
At a glance
Inspections
10
Form 483s
7
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 29 Apr 2026 – 5 May 2026 | Human Drugs | 483 | View 483 → |
| 21 Jun 2023 – 27 Jun 2023 | Human Drugs | 483 | View 483 → |
| 16 Jul 2018 – 27 Jul 2018 | Human Drugs | 483 | View 483 → |
| 21 Sep 2015 – 25 Sep 2015 | Human Drugs | 483 | View 483 → |
| 2 Mar 2012 | Not recorded | 483 | View 483 → |
| 20 Dec 2010 | Not recorded | 483 | On file |
| 11 Jun 2010 | Not recorded | Clean | |
| 22 Jul 2009 | Not recorded | 483 | View 483 → |
| 25 May 2006 | Not recorded | Clean | |
| 28 Apr 2003 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
Investigators
FDA investigators tied to this site in the record.
Ruben C Quintana1 insp.
Karen A Briggs1 insp.
David A Oluwo1 insp.
Marcelo O Mangalindan1 insp.
James M Mason1 insp.
Edward D Mcdonald1 insp.
James P Mcevoy1 insp.
Anita R Michael1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.111 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.115(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.142(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.170(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.182 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.186(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.46(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.81(b)(1)(ii) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Digestive Care Inc's 7 Form 483s
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