Overview
- 10 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-11-02.
At a glance
Inspections
10
Form 483s
4
EIRs
2
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 1 Nov 2023 – 2 Nov 2023 | Human Drugs | 483 | View 483 → |
| 27 Oct 2021 – 4 Nov 2021 | Human Drugs | 483 | View 483 → |
| 20 Feb 2020 – 5 Mar 2020 | Human Drugs | WL | View 483 → |
| 8 Aug 2017 – 11 Aug 2017 | Foods & Cosmetics | 483 | View 483 → |
| 8 Feb 2012 | Not recorded | Clean | |
| 15 Dec 2010 | Not recorded | Clean | |
| 26 Jan 2009 | Not recorded | Clean | |
| 30 Nov 2004 | Not recorded | Clean | |
| 4 Dec 2002 | Not recorded | Clean | |
| 16 Dec 1999 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
4 Nov 2021
21 CFR 211.68(b)
Backup data not assured as exact and complete
Cited by Christopher M Jenner
5 Mar 2020
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Christopher M Jenner, Carrie A Hughes
5 Mar 2020
21 CFR 211.160(a)
Lab controls established, including changes
Cited by Christopher M Jenner, Carrie A Hughes
Investigators
FDA investigators tied to this site in the record.
Christopher M Jenner2 insp.
Timothy T Kapsala2 insp.
Cecilia H Kieu1 insp.
Carrie A Hughes1 insp.
Andrea J Schmidt1 insp.
John A Gonzalez1 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 | 2x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.15(c)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.15(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.365(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.65 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(c)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(2) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind RLC Labs Inc.'s 4 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