Overview
- 6 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-05-10.
At a glance
Inspections
6
Form 483s
6
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 22 Apr 2024 – 10 May 2024 | Human Drugs | 483 | View 483 → |
| 21 Mar 2022 – 4 Apr 2022 | Human Drugs | 483 | View 483 → |
| 10 Dec 2018 – 21 Dec 2018 | Human Drugs | 483 | View 483 → |
| 20 Jun 2017 – 28 Jun 2017 | Human Drugs | 483 | On file |
| 6 Apr 2017 – 18 Apr 2017 | Human Drugs | 483 | View 483 → |
| 30 Mar 2015 – 9 Apr 2015 | Human Drugs | WL | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
10 May 2024
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Jonathan G Matrisciano, Ogechi C Nna, Armen H Youssoufian
10 May 2024
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Jonathan G Matrisciano, Ogechi C Nna, Armen H Youssoufian
10 May 2024
21 CFR 211.67(b)
Written procedures not established/followed
Cited by Jonathan G Matrisciano, Ogechi C Nna, Armen H Youssoufian
10 May 2024
FDCA 503B(a)(10)(B)
Drug product container, fails to include
Cited by Jonathan G Matrisciano, Ogechi C Nna, Armen H Youssoufian
Investigators
FDA investigators tied to this site in the record.
Erik W Koester2 insp.
Nealie C Newberger2 insp.
Jonathan G Matrisciano1 insp.
Ogechi C Nna1 insp.
Armen H Youssoufian1 insp.
Jonah S Ufferfilge1 insp.
Robert J Martin1 insp.
Dien N Nguyen1 insp.
Christopher Janik1 insp.
Maya M Davis1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.42(c)(10)(v) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.111 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.186(b)(9) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.58 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(6) | Cited across public-safe Form 483 observations | 1x |
| FDCA 503B(a)(10)(B) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Brookfield Medical/Surgical Supplies, Inc.'s 6 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