Overview
- 5 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-06-20.
At a glance
Inspections
5
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 12 Jun 2023 – 20 Jun 2023 | Human Drugs | 483 | On file |
| 27 Mar 2018 – 3 Apr 2018 | Human Drugs | Clean | |
| 4 May 2015 – 11 May 2015 | Human Drugs | 483 | View 483 → |
| 1 Mar 2012 | Not recorded | Clean | |
| 28 Jan 2010 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
11 May 2015
21 CFR 211.167(a)
Sterility/pyrogens - test methods written, followed
Cited by Robert M Barbosa
Investigators
FDA investigators tied to this site in the record.
Parul M Patel2 insp.
Wayne D Mcgrath1 insp.
Rodney G Raiford1 insp.
Vilmary Negron Rodriguez1 insp.
Robert M Barbosa1 insp.
Kevin P Foley1 insp.
Charisse K Green1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.167(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Astral SteriTech Private Ltd.'s 3 Form 483s
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