Overview
- 7 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-07-25.
At a glance
Inspections
7
Form 483s
5
EIRs
2
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 21 Jul 2025 – 25 Jul 2025 | Human Drugs | Clean | |
| 18 Sep 2023 – 22 Sep 2023 | Animal Drugs & Feeds | 483 | On file |
| 22 Jan 2020 – 24 Jan 2020 | Human Drugs | 483 | View 483 → |
| 4 Sep 2019 – 6 Sep 2019 | Animal Drugs & Feeds | Clean | |
| 20 May 2019 – 24 May 2019 | Human Drugs | 483 | View 483 → |
| 23 Oct 2017 – 2 Nov 2017 | Human Drugs | 483 | View 483 → |
| 19 Apr 2017 – 21 Apr 2017 | Human Drugs | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
24 Jan 2020
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Rumany C Penn, Claudia M Perez-Kasmarski
24 May 2019
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Joey V Quitania, Eileen A Liu, Anita Narula
24 May 2019
21 CFR 211.110(a)
Written in-process control procedures
Cited by Joey V Quitania, Eileen A Liu, Anita Narula
24 May 2019
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Joey V Quitania, Eileen A Liu, Anita Narula
24 May 2019
21 CFR 211.170(b)
Reserve samples identified, representative, stored
Cited by Joey V Quitania, Eileen A Liu, Anita Narula
Investigators
FDA investigators tied to this site in the record.
Sangeeta M Khurana1 insp.
Wenzheng Zhang1 insp.
Rumany C Penn1 insp.
Claudia M Perez-Kasmarski1 insp.
Santiago Gallardo Johnson1 insp.
Joey V Quitania1 insp.
Eileen A Liu1 insp.
Anita Narula1 insp.
Linda Thai1 insp.
Walden H Lee1 insp.
Jennifer M Gogley1 insp.
Jolanna A Norton1 insp.
Alan P Kurtzberg1 insp.
Kathy Chiu1 insp.
Bichsa T Tran1 insp.
Kathy Kuo1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.170(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b)(7) | 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 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Nitto Avecia Pharma Services, Inc.'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