Overview
- 9 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-02-13.
At a glance
Inspections
9
Form 483s
4
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 6 Feb 2023 – 13 Feb 2023 | Human Drugs | 483 | View 483 → |
| 16 Jan 2018 – 19 Jan 2018 | Human Drugs | 483 | View 483 → |
| 8 Sep 2014 – 11 Sep 2014 | Human Drugs | Clean | |
| 14 Dec 2011 | Not recorded | Clean | |
| 30 Sep 2010 | Not recorded | 483 | View 483 → |
| 4 Sep 2009 | Not recorded | 483 | On file |
| 6 Jul 2007 | Not recorded | Clean | |
| 16 May 2003 | Not recorded | Clean | |
| 12 Jan 2001 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
13 Feb 2023
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Claudia M Perez-Kasmarski, Andrew Le
13 Feb 2023
21 CFR 211.56(b)
Written sanitation procedures not followed
Cited by Claudia M Perez-Kasmarski, Andrew Le
19 Jan 2018
21 CFR 211.192
No written record of investigation
Cited by Taichun Qin, Santiago Gallardo Johnson
19 Jan 2018
21 CFR 211.192
No written record of investigation
Cited by Taichun Qin, Santiago Gallardo Johnson
Investigators
FDA investigators tied to this site in the record.
Esther B Gamallo Herrera2 insp.
Claudia M Perez-Kasmarski1 insp.
Andrew Le1 insp.
Taichun Qin1 insp.
Santiago Gallardo Johnson1 insp.
Diane C Van Leeuwen1 insp.
John A Gonzalez1 insp.
Virgilio F Pacio1 insp.
Zachary A Bogorad1 insp.
Truong X Nguyen1 insp.
Binh T Nguyen1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.194(a)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.194(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(a) | 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 211.56(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind ACTA Laboratories Inc's 4 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