Overview
- 14 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-09-24.
At a glance
Inspections
14
Form 483s
5
EIRs
3
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 9 Sep 2025 – 24 Sep 2025 | Foods & Cosmetics | 483 | View 483 → |
| 3 Feb 2025 – 7 Feb 2025 | Foods & Cosmetics | 483 | On file |
| 17 Nov 2021 – 19 Nov 2021 | Foods & Cosmetics | 483 | On file |
| 17 Oct 2016 – 27 Oct 2016 | Foods & Cosmetics | Clean | |
| 23 May 2016 – 24 May 2016 | Foods & Cosmetics | Clean | |
| 10 Jun 2015 – 25 Jun 2015 | Foods & Cosmetics | 483 | On file |
| 10 May 2013 – 20 May 2013 | Foods & Cosmetics | 483 | On file |
| 24 Nov 2010 | Not recorded | Clean | |
| 5 Nov 2010 | Not recorded | Clean | |
| 17 Feb 2009 | Not recorded | Clean | |
| 3 Jul 2008 | Not recorded | Clean | |
| 31 Mar 2008 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
24 Sep 2025
21 CFR 111.75(a)(1)(i)
Component - verify identity, dietary ingredient
Cited by Meredith P Soehl
24 Sep 2025
21 CFR 111.75(c)(3)
Specifications met identity, purity, strength, comp,; basis
Cited by Meredith P Soehl
Investigators
FDA investigators tied to this site in the record.
Meredith P Soehl7 insp.
Thomas J Mooney4 insp.
Ronald Ifraimov2 insp.
Dana A Razzano1 insp.
Joshua D Lopez1 insp.
Eric J Reisenauer1 insp.
Kwong P Lee1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.70(e) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 111.315(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.70(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.75(a)(1)(i) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.75(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.75(c)(3) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.77(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.15(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.15(d)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.260(l)(1)(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.303 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.315(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.453 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.455(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.553 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.65 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Bactolac Pharmaceutical, Inc.'s 5 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