Somerset Therapeutics Private Limited, Bengaluru: FDA Inspections, Form 483s & Citations

Overview

11 FDA inspections are on record.
9 inspections produced a Form 483.
The most recent recorded inspection date is 2025-02-21.

At a glance

Inspections

Form 483s

EIRs

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

Inspection	Category	Outcome	Form 483
10 Feb 2025 – 21 Feb 2025	Human Drugs	WL	On file
9 Oct 2023 – 27 Oct 2023	Human Drugs	483	On file
24 Mar 2022 – 4 Apr 2022	Human Drugs	483	On file
10 Feb 2020 – 19 Feb 2020	Human Drugs	WL	On file
15 Jul 2019 – 23 Jul 2019	Human Drugs	483	On file
27 Nov 2017 – 5 Dec 2017	Human Drugs	483	On file
17 Apr 2017 – 24 Apr 2017	Human Drugs	Clean
14 Apr 2016 – 22 Apr 2016	Human Drugs	483	On file
12 Aug 2013 – 20 Aug 2013	Human Drugs	483	On file
20 Sep 2011	Not recorded	WL
31 Mar 2009	Not recorded	483	On file

Observations on record

Form 483 observations cited at this site, most recent first.

4 Apr 2022

21 CFR 211.113(b)

Procedures for sterile drug products

Cited by Ileana Barreto-Pettit, Kellia N Hicks

4 Apr 2022

21 CFR 211.192

Investigations of discrepancies, failures

Cited by Ileana Barreto-Pettit, Kellia N Hicks

4 Apr 2022

21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Ileana Barreto-Pettit, Kellia N Hicks

4 Apr 2022

21 CFR 211.42(c)(10)(iv)

Environmental Monitoring System

Cited by Ileana Barreto-Pettit, Kellia N Hicks

23 Jul 2019

21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Samina S Khan

Investigators

FDA investigators tied to this site in the record.

Kellia N Hicks2 insp.

Eileen A Liu1 insp.

Joseph A Piechocki1 insp.

Tamil Arasu1 insp.

Cynthia Jim1 insp.

Ileana Barreto-Pettit1 insp.

Linda F Murphy1 insp.

Steven M Weinman1 insp.

Samina S Khan1 insp.

Ademola O Daramola1 insp.

Nicholas A Violand1 insp.

Jose E Melendez1 insp.

Parul M Patel1 insp.

Jose A Cruz Gonzalez1 insp.

Luis M Burgos Medero1 insp.

Denise M Digiulio1 insp.

Kenneth H Williams1 insp.

Ramon A Hernandez1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

Citation	What it covers	Cited
21 CFR 211.208	Cited across public-safe Form 483 observations	15x
21 CFR 211.68(b)	Cited across public-safe Form 483 observations	15x
21 CFR 211.192	Cited across public-safe Form 483 observations	11x
21 CFR 211.204	Cited across public-safe Form 483 observations	9x
21 CFR 211.48(a)	Cited across public-safe Form 483 observations	9x
21 CFR 211.84(d)(3)	Cited across public-safe Form 483 observations	9x
21 CFR 211.113(b)	Cited across public-safe Form 483 observations	8x
21 CFR 211.84(d)(2)	Cited across public-safe Form 483 observations	8x
21 CFR 211.110(a)	Cited across public-safe Form 483 observations	7x
21 CFR 211.67(b)	Cited across public-safe Form 483 observations	7x
21 CFR 211.100(a)	Cited across public-safe Form 483 observations	6x
21 CFR 211.115(a)	Cited across public-safe Form 483 observations	6x
21 CFR 211.198(a)	Cited across public-safe Form 483 observations	6x
21 CFR 211.22(d)	Cited across public-safe Form 483 observations	6x
21 CFR 211.42(b)	Cited across public-safe Form 483 observations	6x
21 CFR 211.46(c)	Cited across public-safe Form 483 observations	6x
21 CFR 211.68(a)	Cited across public-safe Form 483 observations	6x
21 CFR 211.80(a)	Cited across public-safe Form 483 observations	6x
21 CFR 211.84(d)(1)	Cited across public-safe Form 483 observations	6x
21 CFR 211.160(a)	Cited across public-safe Form 483 observations	5x
21 CFR 211.100(b)	Cited across public-safe Form 483 observations	4x
21 CFR 211.42(c)(10)(iv)	Cited across public-safe Form 483 observations	4x
21 CFR 211.67(c)	Cited across public-safe Form 483 observations	4x
21 CFR 211.110(b)	Cited across public-safe Form 483 observations	3x
21 CFR 211.115(b)	Cited across public-safe Form 483 observations	3x
21 CFR 211.122(a)	Cited across public-safe Form 483 observations	3x
21 CFR 211.184(b)	Cited across public-safe Form 483 observations	3x
21 CFR 211.22(a)	Cited across public-safe Form 483 observations	3x
21 CFR 211.22(c)	Cited across public-safe Form 483 observations	3x
21 CFR 211.42(a)	Cited across public-safe Form 483 observations	3x
21 CFR 211.42(c)(10)(iii)	Cited across public-safe Form 483 observations	3x
21 CFR 211.42(c)(10)(v)	Cited across public-safe Form 483 observations	3x
21 CFR 211.42(c)(10)(vi)	Cited across public-safe Form 483 observations	3x
21 CFR 211.46(b)	Cited across public-safe Form 483 observations	3x
21 CFR 211.63	Cited across public-safe Form 483 observations	3x
21 CFR 211.65(b)	Cited across public-safe Form 483 observations	3x
21 CFR 211.67(b)(1)	Cited across public-safe Form 483 observations	3x
21 CFR 211.67(b)(2)	Cited across public-safe Form 483 observations	3x
21 CFR 211.67(b)(5)	Cited across public-safe Form 483 observations	3x
21 CFR 211.80(b)	Cited across public-safe Form 483 observations	3x
21 CFR 211.84(a)	Cited across public-safe Form 483 observations	3x
21 CFR 211.84(c)(1)	Cited across public-safe Form 483 observations	3x
21 CFR 211.84(c)(3)	Cited across public-safe Form 483 observations	3x
21 CFR 211.84(d)(6)	Cited across public-safe Form 483 observations	3x
21 CFR 211.94(a)	Cited across public-safe Form 483 observations	3x
21 CFR 211.94(d)	Cited across public-safe Form 483 observations	3x
21 CFR 211.25(a)	Cited across public-safe Form 483 observations	2x
21 CFR 211.56(b)	Cited across public-safe Form 483 observations	2x
21 CFR 211.160(b)	Cited across public-safe Form 483 observations	1x
21 CFR 211.165(e)	Cited across public-safe Form 483 observations	1x
21 CFR 211.182	Cited across public-safe Form 483 observations	1x
21 CFR 211.67(a)	Cited across public-safe Form 483 observations	1x

Full site report

Get the verbatim findings behind Somerset Therapeutics Private 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

Somerset Therapeutics Private Limited

Overview

At a glance

Inspection history

Observations on record

Procedures for sterile drug products

Investigations of discrepancies, failures

Procedures not in writing, fully followed

Environmental Monitoring System

Procedures not in writing, fully followed

Procedures for sterile drug products

Procedures not in writing, fully followed

Testing Each Component for Conformity with Specs

Reprocessing procedures lack steps to be taken

Extent of discrepancy, failure investigations

Returned drug procedures in writing and followed

Air recirculation of dust from production areas

Written procedures not established/followed

Components withheld from use pending release

Testing Containers & Closures Conformity with Specs

Absence of Written Procedures

Approval and review of procedures

SOPs not followed / documented

Control procedures to monitor and validate performance

Written in-process control procedures

In-process materials specifications

Validation lacking for sterile drug products

Reprocessing procedures not written or followed

Reprocessing/quality control unit

Written procedures not followed

Following/documenting laboratory controls

Component Test Records

Investigations of discrepancies, failures

Quality control unit review of records

Adverse Drug Experience

Reporting of adverse drug experience to FDA

Associated batches implicated, investigated

Reprocessed returned drug products

No records maintained

Organoleptic examinations sole basis

Records for salvaged drug products

Salvaging and return to marketplace

Salvaging performed without evidence

Authority lacking to review records, investigate errors

Approve or reject procedures or specs

Buildings of Suitable Size, Construction, Location

Adequate space lacking to prevent mix-ups and contamination

Product flow through building is inadequate

Air Supply

Environmental Monitoring System

Cleaning System

Equipment to control conditions

Equipment for Environmental Control

Air filtration system lacking in production area

Plumbing System Defects

Potable water not under positive pressure

Potable water standards not met

Equipment Design, Size and Location

Substances That Come in Contact

Written procedures fail to include

Cleaning SOP/responsibility

Cleaning SOPs/schedules

Cleaning SOPs/equipment protection

Cleaning/maintenance records not kept

Calibration/Inspection/Checking not done

Written calibration / inspection records not kept

Backup data not assured as exact and complete

Backup file not maintained

Computer control of master formula records

input/output verification

Written record not kept of program and validation data

Procedures To Be in Writing

Written Procedures Not Followed

Handling and Storage to Prevent Contamination

Cleaning of Component Containers Prior to Sampling

Sterile Equipment, Aseptic Techniques in sample collecting

Component identity verification

Identity Testing of Each Component

Reports of Analysis (Components)

Certificates of Testing (Containers, Closures)