Overview
- 20 FDA inspections are on record.
- 9 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-06-06.
At a glance
Inspections
20
Form 483s
9
EIRs
4
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 24 May 2023 – 6 Jun 2023 | Human Drugs | 483 | On file |
| 15 Aug 2019 – 22 Aug 2019 | Human Drugs | 483 | On file |
| 22 Feb 2018 – 15 Mar 2018 | Human Drugs | 483 | On file |
| 12 Apr 2017 – 26 Apr 2017 | Human Drugs | Clean | |
| 18 May 2016 – 1 Jun 2016 | Human Drugs | Clean | |
| 3 Mar 2015 | Human Drugs | Clean | |
| 23 Jan 2015 – 6 Feb 2015 | Human Drugs | 483 | On file |
| 20 Oct 2014 – 4 Nov 2014 | Human Drugs | Clean | |
| 17 Jan 2013 | Not recorded | Clean | |
| 7 Mar 2012 | Not recorded | 483 | On file |
| 10 Aug 2011 | Not recorded | 483 | View 483 → |
| 15 Jun 2010 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
10 Aug 2011
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Frederick Razzaghi, Addam S Reynolds
10 Aug 2011
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Frederick Razzaghi, Addam S Reynolds
Investigators
FDA investigators tied to this site in the record.
Paul L Bellamy5 insp.
Nicholas A Violand3 insp.
Frederick Razzaghi2 insp.
Kristy A Zielny2 insp.
Adetutu M Gidado1 insp.
Karishma G Gopaul1 insp.
Russell J Glapion1 insp.
Emmanuel J Ramos1 insp.
Maria Estrella1 insp.
Addam S Reynolds1 insp.
Meredith L Sheridan1 insp.
Donald C Obenhuber1 insp.
Tara R Gooen1 insp.
Justine Tomasso1 insp.
Sean G Casey1 insp.
Daniel J Grabicki1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | 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 Renaissance Lakewood LLC's 9 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