Overview
- 6 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-04-07.
At a glance
Inspections
6
Form 483s
5
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 3 Apr 2023 – 7 Apr 2023 | Human Drugs | 483 | View 483 → |
| 17 Apr 2018 – 23 Apr 2018 | Human Drugs | 483 | View 483 → |
| 22 Apr 2014 – 25 Apr 2014 | Human Drugs | 483 | View 483 → |
| 13 Feb 2013 – 19 Feb 2013 | Human Drugs | 483 | View 483 → |
| 18 Apr 2008 | Not recorded | 483 | On file |
| 5 Apr 2005 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
7 Apr 2023
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Harshal J Desai
Investigators
FDA investigators tied to this site in the record.
Harshal J Desai1 insp.
Saundrea A Munroe1 insp.
Angela E Glenn1 insp.
Ashley A Mutawakkil1 insp.
Ashley Segura1 insp.
Salvatore N Randazzo1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.80(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.105(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.122(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.125(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.170(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(e)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.80(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(3) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Balassa Laboratories Inc.'s 5 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