Overview
- 1 FDA inspection is on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2025-05-15.
At a glance
Inspections
1
Form 483s
1
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 12 May 2025 – 15 May 2025 | Human Drugs | WL | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
15 May 2025
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Xiaohui Shen, Justine Tomasso, Sarah M Gauna
15 May 2025
21 CFR 211.113(b)
Validation lacking for sterile drug products
Cited by Xiaohui Shen, Justine Tomasso, Sarah M Gauna
15 May 2025
21 CFR 211.188(b)(5)
In-process and laboratory control results
Cited by Xiaohui Shen, Justine Tomasso, Sarah M Gauna
15 May 2025
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Xiaohui Shen, Justine Tomasso, Sarah M Gauna
15 May 2025
21 CFR 211.28(a)
Protective Apparel Not Worn
Cited by Xiaohui Shen, Justine Tomasso, Sarah M Gauna
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 |
|---|---|---|
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.188(b)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.28(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(v) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(vi) | Cited across public-safe Form 483 observations | 1x |
| FDCA 503B(b)(2)(A) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Apothecary Pharma LLC's 1 Form 483
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