Overview
- 7 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-08-29.
At a glance
Inspections
7
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 25 Aug 2025 – 29 Aug 2025 | Human Drugs | WL | View 483 → |
| 14 Jan 2020 – 23 Jan 2020 | Human Drugs | 483 | View 483 → |
| 11 Jan 2016 – 14 Jan 2016 | Human Drugs | Clean | |
| 9 Jul 2010 | Not recorded | 483 | On file |
| 20 Apr 2006 | Not recorded | Clean | |
| 19 Sep 2003 | Not recorded | Clean | |
| 8 Jun 2001 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
29 Aug 2025
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Ronda R Loyd Jones, Milton J De Jesus Tavarez
29 Aug 2025
21 CFR 211.142(b)
Storage under appropriate conditions
Cited by Ronda R Loyd Jones, Milton J De Jesus Tavarez
29 Aug 2025
21 CFR 211.165(a)
Testing and release for distribution
Cited by Ronda R Loyd Jones, Milton J De Jesus Tavarez
29 Aug 2025
21 CFR 211.188(b)(1)
Significant Step Accomplishment Dates
Cited by Ronda R Loyd Jones, Milton J De Jesus Tavarez
29 Aug 2025
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Ronda R Loyd Jones, Milton J De Jesus Tavarez
Investigators
FDA investigators tied to this site in the record.
Ronda R Loyd Jones1 insp.
Milton J De Jesus Tavarez1 insp.
Shatina R Alridge1 insp.
Jason R Caballero1 insp.
Albert F Peacock1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.142(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b)(1) | 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 211.63 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(c)(4) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind this site's 3 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