Overview
- 5 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-05-15.
At a glance
Inspections
5
Form 483s
3
EIRs
1
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 13 May 2024 – 15 May 2024 | Human Drugs | Clean | |
| 26 Oct 2021 – 10 Nov 2021 | Human Drugs | 483 | View 483 → |
| 14 Sep 2016 – 28 Sep 2016 | Human Drugs | 483 | View 483 → |
| 18 Feb 2014 – 13 Mar 2014 | Human Drugs | 483 | On file |
| 9 Jan 2006 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
10 Nov 2021
21 CFR 211.113(a)
Procedures for non-sterile drug products
Cited by Brian D Nicholson, Vaishali J Patel
10 Nov 2021
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Brian D Nicholson, Vaishali J Patel
Investigators
FDA investigators tied to this site in the record.
Brian D Nicholson2 insp.
Matthew B Casale1 insp.
Travis V Hull1 insp.
Gabriel Bermudez-Picart1 insp.
Vaishali J Patel1 insp.
Russell K Riley1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.113(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind BMC 1092, 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