Overview
- 9 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-09-05.
At a glance
Inspections
9
Form 483s
2
EIRs
3
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 25 Aug 2025 – 5 Sep 2025 | Foods & Cosmetics | 483 | View 483 → |
| 19 Sep 2024 – 4 Oct 2024 | Foods & Cosmetics | Clean | |
| 25 Sep 2023 – 6 Oct 2023 | Foods & Cosmetics | Clean | |
| 5 Dec 2022 – 20 Dec 2022 | Foods & Cosmetics | Clean | |
| 26 Jul 2021 – 30 Jul 2021 | Foods & Cosmetics | Clean | |
| 15 Nov 2019 – 22 Nov 2019 | Foods & Cosmetics | Clean | |
| 28 Aug 2017 – 29 Aug 2017 | Foods & Cosmetics | Clean | |
| 13 Oct 2015 – 20 Oct 2015 | Foods & Cosmetics | 483 | View 483 → |
| 25 Mar 2014 – 1 May 2014 | Foods & Cosmetics | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
Process preventive controls - Implement
Cited by Desiree C Iya, Kawshalya Pathiraja, Natalie Rodriguez, Ashley S Ertzman, Yuanjie Liu
Sanitation preventive controls - Appropriate (Adequate)
Cited by Desiree C Iya, Kawshalya Pathiraja, Natalie Rodriguez, Ashley S Ertzman, Yuanjie Liu
Process preventive controls - Record review
Cited by Desiree C Iya, Kawshalya Pathiraja, Natalie Rodriguez, Ashley S Ertzman, Yuanjie Liu
Sanitation preventive controls - Implementation records
Cited by Desiree C Iya, Kawshalya Pathiraja, Natalie Rodriguez, Ashley S Ertzman, Yuanjie Liu
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 107.50(e)(2) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 117.135(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.135(c)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.165(a)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.190(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Prolacta Bioscience Inc's 2 Form 483s
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