Overview
- 10 FDA inspections are on record.
- 9 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-07-26.
At a glance
Inspections
10
Form 483s
9
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 16 Jul 2024 – 26 Jul 2024 | Human Drugs | WL | View 483 → |
| 20 Feb 2023 – 28 Feb 2023 | Human Drugs | 483 | View 483 → |
| 7 Oct 2019 – 15 Oct 2019 | Human Drugs | 483 | View 483 → |
| 27 May 2019 – 4 Jun 2019 | Human Drugs | 483 | View 483 → |
| 14 Nov 2018 – 21 Nov 2018 | Human Drugs | 483 | View 483 → |
| 31 Aug 2016 – 4 Sep 2016 | Human Drugs | WL | View 483 → |
| 29 Jun 2015 – 10 Jul 2015 | Human Drugs | 483 | View 483 → |
| 22 Aug 2013 – 30 Aug 2013 | Human Drugs | 483 | View 483 → |
| 23 Feb 2011 | Not recorded | 483 | View 483 → |
| 31 Oct 2005 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
26 Jul 2024
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Wayne D Mcgrath, Saleem A Akhtar
26 Jul 2024
21 CFR 211.113(b)
Validation lacking for sterile drug products
Cited by Wayne D Mcgrath, Saleem A Akhtar
26 Jul 2024
21 CFR 211.160(b)(2)
Acceptance of in-process materials
Cited by Wayne D Mcgrath, Saleem A Akhtar
26 Jul 2024
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Wayne D Mcgrath, Saleem A Akhtar
Investigators
FDA investigators tied to this site in the record.
Jose A Cruz Gonzalez2 insp.
Wayne D Mcgrath1 insp.
Saleem A Akhtar1 insp.
Jeffrey P Raimondi1 insp.
Anastasia M Shields1 insp.
Felix Maldonado1 insp.
Patric C Klotzbuecher1 insp.
Nicholas A Violand1 insp.
Jennifer L Gustavus1 insp.
Tajah L Blackburn1 insp.
Luis M Burgos Medero1 insp.
Ralph H Vocque1 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 | 9x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.182 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.188(b)(11) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.56(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 314.81(b)(1)(ii) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.28(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.34 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(vi) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.52 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.58 | 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(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.80(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Indoco Remedies Limited's 9 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