Overview
- 10 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-01-28.
At a glance
Inspections
10
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 20 Jan 2025 – 28 Jan 2025 | Human Drugs | 483 | View 483 → |
| 4 Nov 2019 – 7 Nov 2019 | Human Drugs | Clean | |
| 18 Sep 2017 – 22 Sep 2017 | Human Drugs | Clean | |
| 20 Jul 2015 – 24 Jul 2015 | Human Drugs | Clean | |
| 19 Sep 2013 – 25 Sep 2013 | Human Drugs | Clean | |
| 15 Aug 2011 | Not recorded | Clean | |
| 16 Jul 2010 | Not recorded | 483 | View 483 → |
| 10 Dec 2008 | Not recorded | 483 | On file |
| 9 May 2006 | Not recorded | Clean | |
| 14 May 2002 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
28 Jan 2025
21 CFR 211.122(a)
Written procedures not followed
Cited by Patty P Kaewussdangkul, Miguel A Martinez
28 Jan 2025
21 CFR 211.125(a)
Strict control not exercised over labeling issued
Cited by Patty P Kaewussdangkul, Miguel A Martinez
28 Jan 2025
21 CFR 211.165(a)
Testing and release for distribution
Cited by Patty P Kaewussdangkul, Miguel A Martinez
28 Jan 2025
21 CFR 211.166(a)
Written program not followed
Cited by Patty P Kaewussdangkul, Miguel A Martinez
28 Jan 2025
21 CFR 211.166(a)(4)
Testing in same container - closure system
Cited by Patty P Kaewussdangkul, Miguel A Martinez
Investigators
FDA investigators tied to this site in the record.
Patty P Kaewussdangkul1 insp.
Miguel A Martinez1 insp.
John A Gonzalez1 insp.
Concepcion Cruz1 insp.
Zachary A Bogorad1 insp.
Azza Talaat1 insp.
Elizabeth D Connell1 insp.
Jose E Melendez1 insp.
Debra M Emerson1 insp.
Rochelle L Cross1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.113(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.122(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.125(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b)(11) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(d) | 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 |
Full site report
Get the verbatim findings behind Bora Pharmaceutical Services Inc's 3 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