Overview
- 10 FDA inspections are on record.
- 7 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-07-11.
At a glance
Inspections
10
Form 483s
7
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 8 Jul 2025 – 11 Jul 2025 | Human Drugs | WL | View 483 → |
| 2 Nov 2021 – 17 Nov 2021 | Human Drugs | 483 | View 483 → |
| 23 Apr 2019 – 2 May 2019 | Foods & Cosmetics | 483 | View 483 → |
| 25 Apr 2018 – 2 May 2018 | Human Drugs | 483 | View 483 → |
| 28 Jul 2014 – 30 Jul 2014 | Human Drugs | 483 | View 483 → |
| 21 Mar 2012 | Not recorded | 483 | On file |
| 12 May 2010 | Not recorded | 483 | View 483 → |
| 25 Sep 2007 | Not recorded | Clean | |
| 28 Sep 2005 | Not recorded | Clean | |
| 10 Sep 2002 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
11 Jul 2025
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Syeda N Mahazabin, Nelson N Ayangho, Young K Chou
11 Jul 2025
21 CFR 211.165(a)
Testing and release for distribution
Cited by Syeda N Mahazabin, Nelson N Ayangho, Young K Chou
11 Jul 2025
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Syeda N Mahazabin, Nelson N Ayangho, Young K Chou
11 Jul 2025
21 CFR 211.68(b)
Computer control of master formula records
Cited by Syeda N Mahazabin, Nelson N Ayangho, Young K Chou
Investigators
FDA investigators tied to this site in the record.
Syeda N Mahazabin1 insp.
Nelson N Ayangho1 insp.
Young K Chou1 insp.
Constantin Y Philopoulos1 insp.
Theodore N Sietsema1 insp.
Bei Y He1 insp.
Meisha R Sampson1 insp.
Meisha R Waters1 insp.
Martha Sullivan Myrick1 insp.
Sarah M Napier1 insp.
Patsy J Domingo1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 111.320(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.101(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.170(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(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 Tower Laboratories Ltd.'s 7 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