Overview
- 10 FDA inspections are on record.
- 7 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-06-19.
At a glance
Inspections
10
Form 483s
7
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 9 Jun 2025 – 19 Jun 2025 | Human Drugs | 483 | View 483 → |
| 9 Oct 2023 – 18 Oct 2023 | Human Drugs | WL | View 483 → |
| 2 Mar 2020 – 6 Mar 2020 | Human Drugs | 483 | On file |
| 30 May 2019 – 6 Jun 2019 | Human Drugs | 483 | On file |
| 16 Jan 2017 – 24 Jan 2017 | Human Drugs | 483 | View 483 → |
| 29 Feb 2016 – 7 Mar 2016 | Human Drugs | 483 | On file |
| 19 May 2014 – 23 May 2014 | Human Drugs | 483 | On file |
| 18 Nov 2011 | Not recorded | Clean | |
| 12 Feb 2009 | Not recorded | Clean | |
| 14 Oct 2005 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
19 Jun 2025
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Wayne D Mcgrath, Arsen Karapetyan
19 Jun 2025
21 CFR 211.113(b)
Validation lacking for sterile drug products
Cited by Wayne D Mcgrath, Arsen Karapetyan
19 Jun 2025
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Wayne D Mcgrath, Arsen Karapetyan
19 Jun 2025
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Wayne D Mcgrath, Arsen Karapetyan
19 Jun 2025
21 CFR 211.42(a)
Buildings of Suitable Size, Construction, Location
Cited by Wayne D Mcgrath, Arsen Karapetyan
Investigators
FDA investigators tied to this site in the record.
Wayne D Mcgrath1 insp.
Arsen Karapetyan1 insp.
Saleem A Akhtar1 insp.
Pratik S Upadhyay1 insp.
Tamil Arasu1 insp.
Zhaoyang Meng1 insp.
Marcellinus D Dordunoo1 insp.
Patric C Klotzbuecher1 insp.
Anastasia M Shields1 insp.
Linda F Murphy1 insp.
Daniel J Roberts1 insp.
Luis A Dasta1 insp.
Matthew B Casale1 insp.
Michael A Charles1 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 | 4x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(8) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.81(b)(1)(i) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind NATCO Pharma Limited'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