Overview
- 16 FDA inspections are on record.
- 12 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-07-12.
At a glance
Inspections
16
Form 483s
12
EIRs
1
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 8 Jul 2024 – 12 Jul 2024 | Human Drugs | Clean | |
| 1 May 2023 – 12 May 2023 | Human Drugs | WL | View 483 → |
| 22 Jul 2019 – 2 Aug 2019 | Human Drugs | 483 | View 483 → |
| 10 Dec 2018 – 14 Dec 2018 | Human Drugs | 483 | On file |
| 13 Aug 2018 – 17 Aug 2018 | Human Drugs | Clean | |
| 31 May 2018 – 8 Jun 2018 | Animal Drugs & Feeds | 483 | View 483 → |
| 24 Jul 2017 – 31 Jul 2017 | Human Drugs | 483 | View 483 → |
| 1 Jun 2017 – 9 Jun 2017 | Human Drugs | Clean | |
| 13 Feb 2017 – 17 Feb 2017 | Human Drugs | 483 | On file |
| 9 Jun 2016 – 17 Jun 2016 | Human Drugs | 483 | On file |
| 30 Mar 2015 – 7 Apr 2015 | Human Drugs | 483 | View 483 → |
| 10 Jun 2013 – 21 Jun 2013 | Human Drugs | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
12 May 2023
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Justin A Boyd, Rita K Kabaso, Arsen Karapetyan, Rita K Vick
12 May 2023
21 CFR 211.113(a)
Procedures for non-sterile drug products
Cited by Justin A Boyd, Rita K Kabaso, Arsen Karapetyan, Rita K Vick
12 May 2023
21 CFR 211.113(b)
Validation lacking for sterile drug products
Cited by Justin A Boyd, Rita K Kabaso, Arsen Karapetyan, Rita K Vick
12 May 2023
21 CFR 211.165(e)
Test methods
Cited by Justin A Boyd, Rita K Kabaso, Arsen Karapetyan, Rita K Vick
12 May 2023
21 CFR 211.180(e)(1)
Representative Number of Batches for Annual Review
Cited by Justin A Boyd, Rita K Kabaso, Arsen Karapetyan, Rita K Vick
Investigators
FDA investigators tied to this site in the record.
Rita K Kabaso2 insp.
Nicola M Fenty-Stewart1 insp.
Arindam Dasgupta1 insp.
Li-Hong P Yeh1 insp.
Justin A Boyd1 insp.
Arsen Karapetyan1 insp.
Rita K Vick1 insp.
Yasamin Ameri1 insp.
Thomas J Arista1 insp.
Vilmary Negron Rodriguez1 insp.
Andrew J Idzior1 insp.
Matthew B Casale1 insp.
Abby E Pelletier1 insp.
Steven P Donald1 insp.
Tonia F Bernard1 insp.
Unnee Ranjan1 insp.
Lucila B Nwatu1 insp.
Debra I Love1 insp.
Eileen A Liu1 insp.
Narong Chamkasem1 insp.
Stephen D Brown1 insp.
Torrance J Slayton1 insp.
Neil J Bonzagni1 insp.
Barbara D Paul1 insp.
Kevin P Foley1 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 | 6x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.84(c)(4) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.111 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.42(c)(10)(v) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.113(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(e)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(iii) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.46(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.46(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b)(4) | 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 Intas Pharmaceuticals Limited's 12 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