Home / Facilities / 3009395771

Sun Pharmaceutical Industries, Inc. FDA Inspection Record

FEI 3009395771 · Inspections, Form 483s, warning letters and import refusals

Sun Pharmaceutical Industries, Inc. is an FDA-registered facility (FEI 3009395771) located in Billerica, MA, US. Registered operations: ANALYSIS; LABEL; MANUFACTURE; PACK. RegDataLab tracks 14 FDA inspections at this facility.

What FDA found at this site

Latest inspection
Apr 18, 2025: Voluntary Action Indicated (VAI)
Inspections on record
14 (10 VAI, 4 NAI)
Last OAI inspection
None on record
Warning letters
None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
Recalls as the recalling firm
3, latest Jun 6, 2018

A Form 483 lists an inspector's observations. OAI means FDA recommends regulatory and/or administrative action. A warning letter is FDA's formal enforcement notice. No record here does not establish that a site is safe. Check this site on FDA's Data Dashboard.

Inspections and what FDA cited

Showing the 10 most recent of 14 inspections. Citations are the inspector observations FDA publishes for the inspection.

DateResultWhat FDA cited
Apr 18, 2025Voluntary Action Indicated (VAI)Procedures not in writing, fully followed (21 CFR 211.22(d))
Equipment Design, Size and Location (21 CFR 211.63)
Defined areas of adequate size for operations (21 CFR 211.42(c))
Cleaning / Sanitizing / Maintenance (21 CFR 211.67(a))
and 5 more
Dec 23, 2019Voluntary Action Indicated (VAI)No citations listed
Mar 19, 2018No Action Indicated (NAI)No citations listed
Dec 20, 2017No Action Indicated (NAI)No citations listed
Nov 13, 2017Voluntary Action Indicated (VAI)No citations listed
Jun 29, 2016Voluntary Action Indicated (VAI)Procedures not in writing, fully followed (21 CFR 211.22(d))
Components withheld from use pending release (21 CFR 211.84(a))
Investigations of discrepancies, failures (21 CFR 211.192)
Contamination, chemical or physical change, deterioration (21 CFR 314.81(b)(1)(ii))
Jun 29, 2016No Action Indicated (NAI)No citations listed
Jan 13, 2015Voluntary Action Indicated (VAI)No citations listed
Sep 17, 2014Voluntary Action Indicated (VAI)Training , Education , Experience overall (21 CFR 211.25(a))
Calibration/Inspection/Checking not done (21 CFR 211.68(a))
Procedures for sterile drug products (21 CFR 211.113(b))
Test methods (21 CFR 211.165(e))
and 2 more
Nov 30, 2012Voluntary Action Indicated (VAI)No citations listed

Recalls

Newest first. Recalls FDA's Enforcement Report lists with this FEI as the recalling firm. The recalling firm is not always the site that made the product. Search FDA's Enforcement Report by recall number.

DateClassRecallProduct and reason
Jun 6, 2018Class IID-1040-2018Kit for the Preparation of Technetium Tc99m Medronate, 20mg in 10 mL vial, packaged in a)…
Lack of assurance of sterility: Technetium TC-99M Medronate Kit has a reported breach of sterility.
Apr 10, 2018Class IID-0815-2018Kit for the Preparation of Technetium TC-99M Mebrofenin, 45 mg in 10 mL (5 count), NDC…
Failed Stability Specifications
May 30, 2013Class IIID-808-2013Pharmalucence Kit for the Preparation of Technetium Tc 99m Sestamibi Injection for…
Presence of Particulate Matter; particulate found in retain samples

When each source was last refreshed

FDA sources behind this page and when RegDataLab last refreshed each one
RecordsLast refreshedSource as ofStatus
InspectionsNov 14, 2026Newest record Nov 5, 2026Current
Inspection citationsNov 14, 2026Newest record Nov 5, 2026Current
Compliance actions (warning letters, injunctions and other action types)Nov 2, 2026Newest record Oct 29, 2026Current
Warning letter textNov 14, 2026Newest record Nov 10, 2026Current
Recalls (Enforcement Report)Nov 14, 2026Newest record Nov 11, 2026Current
Form 483s and inspection documentsNov 13, 2026Newest record Nov 12, 2026Current
Import refusalsNov 2, 2026Newest record Oct 22, 2026Current

Reviewing Sun Pharmaceutical Industries, Inc. as a supplier? Request a free FDA snapshot: name up to five suppliers and get a PDF of their public FDA record, with sources and dates. You do not need an API connection. Each snapshot is prepared by hand.

Check this supplier

Or check Sun Pharmaceutical Industries, Inc. yourself in Claude, Cursor or ChatGPT: get the full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site.

Get a free API key

Facility details

Company
Sun Pharmaceutical Industries, Inc.
Location
Billerica, MA (US)
Registration Expires
Dec 31, 2027
Operations
ANALYSIS; LABEL; MANUFACTURE; PACK
Source
decrs

FDA data resources

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.