Overview
- 7 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-01-26.
At a glance
Inspections
7
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 23 Jan 2024 – 26 Jan 2024 | Human Drugs | 483 | On file |
| 24 Aug 2021 – 27 Aug 2021 | Human Drugs | 483 | View 483 → |
| 31 Oct 2016 – 2 Nov 2016 | Human Drugs | Clean | |
| 7 Apr 2014 – 8 Apr 2014 | Human Drugs | Clean | |
| 5 Oct 2011 | Not recorded | Clean | |
| 6 Jan 2010 | Not recorded | Clean | |
| 20 Jul 2007 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
27 Aug 2021
21 CFR 211.22(a)
Authority lacking to review records, investigate errors
Cited by Bei Y He, Lori B Wikstrom
27 Aug 2021
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Bei Y He, Lori B Wikstrom
27 Aug 2021
21 CFR 211.58
Buildings not maintained in good state of repair
Cited by Bei Y He, Lori B Wikstrom
27 Aug 2021
21 CFR 211.68(b)
Computer control of master formula records
Cited by Bei Y He, Lori B Wikstrom
Investigators
FDA investigators tied to this site in the record.
Steven D Kehoe2 insp.
Matthew M Schuckmann1 insp.
Melissa M Steiger1 insp.
Bei Y He1 insp.
Lori B Wikstrom1 insp.
Tiara N Brown-Crosen1 insp.
Jonathan R Campos1 insp.
Victoria A Wagoner1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.22(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.58 | 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 R.D. Laboratories, Inc.'s 2 Form 483s
Source PDFs 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