Overview
- 7 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-05-20.
At a glance
Inspections
7
Form 483s
4
EIRs
2
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 13 May 2026 – 20 May 2026 | Human Drugs | 483 | On file |
| 20 Mar 2023 – 27 Mar 2023 | Human Drugs | 483 | On file |
| 28 Jan 2019 – 5 Feb 2019 | Human Drugs | Clean | |
| 7 Feb 2017 – 10 Feb 2017 | Human Drugs | 483 | View 483 → |
| 26 Apr 2016 – 27 Apr 2016 | Human Drugs | Clean | |
| 2 Jun 2011 | Not recorded | 483 | On file |
| 6 May 2010 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
10 Feb 2017
21 CFR 211.68(b)
Computer control of master formula records
Cited by Santos E Camara, Walden H Lee
Investigators
FDA investigators tied to this site in the record.
Joey V Quitania1 insp.
Miguel A Martinez1 insp.
Navneet Kaur1 insp.
Tareq W Haddad1 insp.
Kamyl Y Guzman Morales1 insp.
Cecilia H Kieu1 insp.
Santiago Gallardo Johnson1 insp.
Santos E Camara1 insp.
Walden H Lee1 insp.
Linda Thai1 insp.
Virgilio F Pacio1 insp.
Kim L Thomas Cruse1 insp.
Deborah A Greco1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.48(a) | 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 Bachem Americas, Inc.'s 4 Form 483s
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