Overview
- 5 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-06-09.
At a glance
Inspections
5
Form 483s
5
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 12 May 2025 – 9 Jun 2025 | Human Drugs | WL | On file |
| 23 Sep 2024 – 22 Oct 2024 | Animal Drugs & Feeds | WL | View 483 → |
| 9 Aug 2023 – 29 Aug 2023 | Human Drugs | 483 | View 483 → |
| 17 Aug 2021 – 8 Sep 2021 | Human Drugs | 483 | View 483 → |
| 5 Jun 2017 – 16 Jun 2017 | Human Drugs | WL | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
Procedures for sterile drug products
Cited by Christina K Theodorou, Juanita P Versace, Julia N Alvarez, Rahi D Patel
Testing and release for distribution
Cited by Christina K Theodorou, Juanita P Versace, Julia N Alvarez, Rahi D Patel
Investigations of discrepancies, failures
Cited by Christina K Theodorou, Juanita P Versace, Julia N Alvarez, Rahi D Patel
Approve or reject components, products
Cited by Christina K Theodorou, Juanita P Versace, Julia N Alvarez, Rahi D Patel
Reports of Analysis (Components)
Cited by Christina K Theodorou, Juanita P Versace, Julia N Alvarez, Rahi D Patel
Investigators
FDA investigators tied to this site in the record.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| FDCA 501(a)(2)(A) | Cited across public-safe Form 483 observations | 10x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(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(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(2) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Boothwyn Pharmacy LLC's 5 Form 483s
Source PDFs 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