Overview
- 7 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-05-30.
At a glance
Inspections
7
Form 483s
5
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 23 May 2025 – 30 May 2025 | Human Drugs | 483 | On file |
| 7 Oct 2019 – 11 Oct 2019 | Human Drugs | 483 | On file |
| 16 Apr 2018 – 19 Apr 2018 | Human Drugs | 483 | On file |
| 27 Nov 2017 – 1 Dec 2017 | Human Drugs | 483 | On file |
| 25 Jul 2016 – 29 Jul 2016 | Human Drugs | Clean | |
| 30 Jun 2014 – 4 Jul 2014 | Human Drugs | 483 | View 483 → |
| 31 May 2011 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
4 Jul 2014
21 CFR 211.68(b)
Computer control of master formula records
Cited by Michael H Tollon, Kim L Thomas Cruse
4 Jul 2014
21 CFR 211.160(b)(3)
Drug products-sampling procedures/specifications
Cited by Michael H Tollon, Kim L Thomas Cruse
4 Jul 2014
21 CFR 211.160(b)(4)
Establishment of calibration procedures
Cited by Michael H Tollon, Kim L Thomas Cruse
4 Jul 2014
21 CFR 211.166(a)
Lack of written stability program
Cited by Michael H Tollon, Kim L Thomas Cruse
4 Jul 2014
21 CFR 211.194(c)
Testing and standardization of standards et. al.
Cited by Michael H Tollon, Kim L Thomas Cruse
Investigators
FDA investigators tied to this site in the record.
Michele L Glendenning1 insp.
Sandra A Boyd1 insp.
Tajah L Blackburn1 insp.
Justin A Boyd1 insp.
Parul M Patel1 insp.
Michael H Tollon1 insp.
Kim L Thomas Cruse1 insp.
Nancy G Schmidt1 insp.
Marianela Aponte Cruz1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.160(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Douglas Manufacturing Limited's 5 Form 483s
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