Overview
- 110 inspections across 103 sites are on record.
- 186 Form 483 observations are attributed to this investigator.
- Most recent recorded activity is 2026-05-01.
About Tamil Arasu
Tamil Arasu, also written Tamilarasu, is an FDA investigator with 110 inspections at 103 sites and 186 Form 483 observations on record since November 2014. The most recent inspection on record was in Derabassi, India in May 2026. The published record holds 25 of the resulting Form 483s, 22 of them for human drug facilities.
Since 2023 the work has been mostly overseas. Seven of the 25 forms went to Indian facilities, including Ajanta Pharma in Paithan in April 2026, Cipla in Salcette, Goa, Micro Labs and Watson Pharma in Verna, and Glenmark and Medgel in Dhar. Four went to Southeast Asia in late 2024: Vantive Manufacturing in Singapore and Thailand, Haw Par Healthcare in Singapore and International Laboratories in Bang Phli. Earlier forms cover New Jersey and New York, including Akorn in Somerset (22 observations, the longest on record) and Mylan in Morgantown.
The section cited most is 21 CFR 211.192, investigations of discrepancies and failures, followed by 211.22(d) quality unit procedures and 211.160(b) laboratory controls. Unnee Ranjan co-signed four of the 25 forms and Saleem A Akhtar three. Our guide to FDA investigators and their inspection history explains how to prepare for an inspector with a record like this.
At a glance
Inspections
110
Sites
103
Observations
186
Career since
Nov 2014
Form 483s on record
Every Form 483 in the published record that names Tamil Arasu, most recent first.
| Issued | Company and facility | Category | Observations |
|---|---|---|---|
| 21 Apr 2026 | Ajanta Pharma Ltd.Paithan, India | Human Drugs | 5 |
| 19 Dec 2025 | Laboratorios Jaloma S.A. de C.V.Guadalajara, Mexico | Human Drugs | 4 |
| 30 May 2025 | Micro Labs LimitedVerna, India | Human Drugs | 2 |
| 20 May 2025 | Watson Pharma Private LimitedVerna, India | Human Drugs | 3 |
| 5 May 2025 | Geri-Care Pharmaceuticals Corp.Lakewood, United States | Human Drugs | 5 |
| 21 Feb 2025 | MEDGEL PRIVATE LIMITEDPithampur, Dhar, India | Human Drugs | 7 |
| 14 Feb 2025 | Glenmark Pharmaceuticals LimitedDhar, India | Human Drugs | 5 |
| 13 Dec 2024 | Vantive Manufacturing Pte. Ltd.Singapore, Singapore | Human Drugs | 3 |
| 3 Dec 2024 | Vantive Manufacturing (Thailand) CompanyPluak Daeng, Thailand | Human Drugs | 6 |
| 27 Sep 2024 | Haw Par Healthcare Ltd.Singapore, Singapore | Human Drugs | 7 |
| 20 Sep 2024 | International Laboratories Corp., LimitedBang Phli, Thailand | Human Drugs | 7 |
| 21 Jun 2024 | Cipla LimitedSalcette, India | Human Drugs | 6 |
| 11 Aug 2023 | SOFIE Co. dba SofieTotowa, United States | Human Drugs | 4 |
| 25 Jul 2019 | Mylan Pharmaceuticals IncMorgantown, United States | Human Drugs | 10 |
| 5 Feb 2019 | Sun Pharmaceutical Medicare LimitedHalol, India | Human Drugs | 2 |
| 23 Jan 2019 | Tris Pharma Inc.Monmouth Junction, United States | Human Drugs | 2 |
| 30 Aug 2018 | Akorn Inc.Somerset, United States | Human Drugs | 22 |
| 15 Feb 2018 | Cosette Pharmaceuticals, Inc.South Plainfield, United States | Human Drugs | 12 |
| 11 Jan 2018 | CMIC CMO USA CorporationCranbury, United States | Human Drugs | 5 |
| 25 Mar 2016 | Apria Healthcare LLCLakewood, United States | Human Drugs | 1 |
| 3 Feb 2016 | Lincare IncFarmingdale, United States | Human Drugs | 3 |
| 10 Mar 2015 | Micra Biotechnologies IncRiver Edge, United States | Human Drugs | 6 |
| 8 Jan 2015 | Peoples Bakery Inc.Trenton, United States | Foods & Cosmetics | 4 |
| 24 Nov 2014 | 4C Foods Corp.Brooklyn, United States | Foods & Cosmetics | 3 |
| 24 Nov 2014 | Healthy Delites, Inc.Brooklyn, United States | Foods & Cosmetics | 7 |
Regulations cited most
How many of Tamil Arasu's Form 483s cite each section of the Code of Federal Regulations.
| Regulation | What it covers | Form 483s citing it |
|---|---|---|
| 21 CFR 211.192 | Production record review and investigation of discrepancies | 5 |
| 21 CFR 211.22(d) | Responsibilities of the quality control unit | 4 |
| 21 CFR 211.160(b) | Laboratory controls, general requirements | 3 |
| 21 CFR 211.110(a) | Sampling and testing of in-process materials | 3 |
| 21 CFR 211.166(a) | Stability testing | 2 |
| 21 CFR 211.165(e) | Testing and release for distribution | 2 |
| 21 CFR 211.194(a)(8) | Laboratory records | 2 |
| 21 CFR 211.194(a) | Laboratory records | 1 |
Recent inspections
Most recent inspections in the published record.
| Site | Date | Category | Form 483 |
|---|---|---|---|
| SCL Lifesciences Limited | 1 May 2026 | Human Drugs | On file |
| Wockhardt Limited | 24 Apr 2026 | Human Drugs | |
| Ajanta Pharma Ltd. | 21 Apr 2026 | Human Drugs | View 483 → |
| MicroBiopharm Japan Co., Ltd. | 13 Feb 2026 | Human Drugs | On file |
| Yuki Gosei Kogyo Co., Ltd. | 6 Feb 2026 | Human Drugs | On file |
Sites inspected
Co-investigators
Investigators who co-signed a Form 483 with Tamil Arasu.
- Unnee Ranjan4 shared 483s
- Saleem A Akhtar3 shared 483s
- Lauren N Howard2 shared 483s
- Wayne D Mcgrath2 shared 483s
- David J Gomes2 shared 483s
- Samantha E Cleek2 shared 483s
- Guerlain Ulysse2 shared 483s
- Kimberley A Ricketts2 shared 483s
- Nibin Varghese1 shared 483
- Jose M Cayuela1 shared 483
- Alisha B Patel1 shared 483
- Eileen A Liu1 shared 483
- Joseph A Piechocki1 shared 483
- Rose L Jean-Mary1 shared 483
- John P Mistler1 shared 483
- Sean R Marcsisin1 shared 483
- Thomas J Arista1 shared 483
- Russell J Glapion1 shared 483
- Jose O Hernandez1 shared 483
- Ko U Min1 shared 483
Full investigator report
Get the verbatim findings behind Tamil Arasu's 186 observations
Source 483 PDFs, verbatim observations, and how each site responded, so your team knows what they cite before they arrive.
- New inspections and Form 483s, mapped to the CFR citation
- Warning letter outcomes, and the citation patterns they repeat
- Their co-investigators, so no surprises about who shows up on site