Overview
- 16 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-08-07.
At a glance
Inspections
16
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 24 Jul 2023 – 7 Aug 2023 | Human Drugs | 483 | View 483 → |
| 19 Mar 2018 – 29 Mar 2018 | Medical Devices & Rad Health | 483 | View 483 → |
| 12 Feb 2018 – 14 Feb 2018 | Medical Devices & Rad Health | Clean | |
| 27 Apr 2015 – 5 May 2015 | Medical Devices & Rad Health | Clean | |
| 6 Feb 2014 – 7 Feb 2014 | Medical Devices & Rad Health | Clean | |
| 4 Oct 2012 | Not recorded | Clean | |
| 7 Oct 2011 | Not recorded | Clean | |
| 3 Jun 2011 | Not recorded | 483 | View 483 → |
| 13 Oct 2010 | Not recorded | Clean | |
| 12 May 2010 | Not recorded | Clean | |
| 25 Mar 2009 | Not recorded | Clean | |
| 22 Apr 2008 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
7 Aug 2023
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Gam S Zamil, Karishma G Gopaul
7 Aug 2023
21 CFR 211.160(a)
Following/documenting laboratory controls
Cited by Gam S Zamil, Karishma G Gopaul
7 Aug 2023
21 CFR 211.160(b)(4)
Establishment of calibration procedures
Cited by Gam S Zamil, Karishma G Gopaul
7 Aug 2023
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Gam S Zamil, Karishma G Gopaul
Investigators
FDA investigators tied to this site in the record.
Robert C Steyert2 insp.
Gam S Zamil1 insp.
Karishma G Gopaul1 insp.
Jacqueline S Warner1 insp.
Robert C Horan1 insp.
Demitria J Xiradakis1 insp.
Charisse K Green1 insp.
James A Liubicich1 insp.
Ronald Ifraimov1 insp.
Uduak M Inokon1 insp.
Alice S Tsao1 insp.
Thomas J Mooney1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.72(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.80(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.103 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(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 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Sciarra Laboratories, Inc.'s 3 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