Overview
- 28 FDA inspections are on record.
- 11 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-11-07.
At a glance
Inspections
28
Form 483s
11
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 3 Nov 2025 – 7 Nov 2025 | Human Drugs | 483 | On file |
| 31 Mar 2025 – 3 Apr 2025 | Human Drugs | Clean | |
| 20 Feb 2024 – 1 Mar 2024 | Human Drugs | 483 | On file |
| 14 Jun 2021 – 22 Jun 2021 | Human Drugs | 483 | View 483 → |
| 18 Nov 2019 – 22 Nov 2019 | Human Drugs | Clean | |
| 18 Nov 2019 – 21 Nov 2019 | Human Drugs | Clean | |
| 23 Jul 2019 – 25 Jul 2019 | Human Drugs | Clean | |
| 5 Feb 2019 – 12 Feb 2019 | Human Drugs | 483 | View 483 → |
| 13 Mar 2017 – 31 Mar 2017 | Medical Devices & Rad Health | 483 | View 483 → |
| 9 Jul 2014 – 8 Aug 2014 | Human Drugs | 483 | View 483 → |
| 27 Feb 2014 – 3 Mar 2014 | Human Drugs | Clean | |
| 21 Aug 2012 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
22 Jun 2021
21 CFR 211.42(c)(10)(vi)
Equipment to control conditions
Cited by Uttaniti Limchumroon, Marcus F Yambot, James B Arnett
22 Jun 2021
21 CFR 820.30(f)
Design verification - Lack of or inadequate procedures
Cited by Uttaniti Limchumroon, Marcus F Yambot, James B Arnett
22 Jun 2021
21 CFR 820.30(g)
Design validation- Lack of or inadequate procedures
Cited by Uttaniti Limchumroon, Marcus F Yambot, James B Arnett
22 Jun 2021
21 CFR 820.30(h)
Design transfer - Lack of or inadequate procedures
Cited by Uttaniti Limchumroon, Marcus F Yambot, James B Arnett
12 Feb 2019
21 CFR 211.100(b)
SOPs not followed / documented
Cited by Ashar P Parikh, Philip F Istafanos
Investigators
FDA investigators tied to this site in the record.
Carla J Lundi4 insp.
Uttaniti Limchumroon3 insp.
Sonya L Karsik3 insp.
Samson O Oluseye2 insp.
Walden H Lee2 insp.
Marcus F Yambot2 insp.
Jennifer M Gogley2 insp.
John A Gonzalez2 insp.
Virgilio F Pacio2 insp.
Mark C Saale2 insp.
Kara A Scheibner1 insp.
Grace P Santos1 insp.
Michael T Cyrus1 insp.
Crystal Monroy1 insp.
Lillian S Wu1 insp.
Rachel C Stanton1 insp.
Homero W Aguilar1 insp.
James B Arnett1 insp.
Himanshu Gupta1 insp.
Lakecha N Lewis1 insp.
Iris C Macinnes1 insp.
Srinivas Chennamaneni1 insp.
Mark W Babbitt1 insp.
Ashar P Parikh1 insp.
Philip F Istafanos1 insp.
Jeffrey P Raimondi1 insp.
Carrie A Hughes1 insp.
Amanda L Fyles1 insp.
Amir Alavi1 insp.
Xiaohui Shen1 insp.
Ling-Yu L Liu1 insp.
Bichsa T Tran1 insp.
Yvonne Y Wu1 insp.
Truong X Nguyen1 insp.
James R Fleckenstein1 insp.
Jinnie Kokiatkulkij1 insp.
David Serrano1 insp.
Lilly O Barton1 insp.
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 | 12x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 11x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 9x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 8x |
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 211.188 | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 820.30(f) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 211.180(b) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 211.80(a) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 820.30(b) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 820.30(c) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 820.30(d) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(e)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.184(e) | 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 211.42(c)(10)(vi) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.87 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.94(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 310.305(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.80(c)(1)(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.81(b)(1)(ii) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.81(b)(2)(iv)(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(h) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Amphastar Pharmaceuticals, Inc.'s 11 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