Overview
- 8 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-02-11.
At a glance
Inspections
8
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 4 Feb 2025 – 11 Feb 2025 | Biologics | 483 | View 483 → |
| 8 Feb 2023 – 16 Feb 2023 | Biologics | 483 | View 483 → |
| 13 Nov 2019 – 15 Nov 2019 | Biologics | Clean | |
| 25 Oct 2017 – 27 Oct 2017 | Biologics | Clean | |
| 19 Jan 2016 – 22 Jan 2016 | Biologics | Clean | |
| 22 Jul 2014 – 28 Jul 2014 | Biologics | Clean | |
| 24 May 2011 | Not recorded | Clean | |
| 18 Sep 2009 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
11 Feb 2025
21 CFR 1271.195(c)
Monitoring--cross contamination, exposure to CD
Cited by Amy A Johnson, Kenneth L Smalls, Chanel E Crawford
11 Feb 2025
21 CFR 1271.260(e)
Temperature limits
Cited by Amy A Johnson, Kenneth L Smalls, Chanel E Crawford
16 Feb 2023
21 CFR 1271.160(b)(6)
Deviations--Investigation, documenting, trending
Cited by Amy A Johnson, Kenneth L Smalls
16 Feb 2023
21 CFR 1271.160(b)(6)
Deviations--Investigation, documenting, trending
Cited by Amy A Johnson, Kenneth L Smalls
16 Feb 2023
21 CFR 1271.160(b)(6)
Deviations--Investigation, documenting, trending
Cited by Amy A Johnson, Kenneth L Smalls
Investigators
FDA investigators tied to this site in the record.
Kenneth L Smalls5 insp.
Amy A Johnson4 insp.
Amy C Amaro2 insp.
Wilfred A Darang2 insp.
Chanel E Crawford1 insp.
Richard J Bashay1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 1271.160(b)(6) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 1271.180(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 1271.200(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 1271.225 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 1271.160(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.195(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.260(e) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind this site'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