Drug factory · FDA FEI 3004610460

Baxter Pharmaceuticals India Private Limited

Village Vasana-Chacharwadi, Taluka Sanand, Ahmedabad, India

Serious problems, FDA action at FDA's last inspection, Jan 27, 2023.

Official Action Indicated: inspectors found significant problems and FDA recommended regulatory action, such as a warning letter or import alert.

9 drug inspections on record since 2009: 0 with no problems, 6 with problems fixed voluntarily, 3 with FDA action.

What it does, for whom

Drug	Role	For	NDC
Dexmedetomidine	Makes it, tests it, packages it, labels it and sterilizes it	Baxter Healthcare Corporation	36000-262
Ephedrine	Makes it, tests it, packages it, labels it and sterilizes it	Baxter Healthcare Corporation	36000-336
Flumazenil	Makes it, tests it, packages it, labels it and sterilizes it	Baxter Healthcare Corporation	36000-148, 36000-149
Furosemide	Makes it, tests it, packages it, labels it and sterilizes it	Baxter Healthcare Corporation, Civica, Inc.	36000-063, 36000-064, 36000-065 +4
Levocarnitine	Makes it, tests it, packages it, labels it and sterilizes it	Baxter Healthcare Corporation	36000-368
Levofloxacin	Makes it, tests it, packages it, labels it and sterilizes it	Baxter Healthcare Corporation	36000-045, 36000-046, 36000-047 +1
Metoclopramide	Makes it, tests it, packages it, labels it and sterilizes it	Baxter Healthcare Corporation	36000-366
Metoprolol	Makes it, tests it, packages it, labels it and sterilizes it	Baxter Healthcare Corporation	36000-033
Ondansetron	Makes it, tests it, packages it, labels it and sterilizes it	Baxter Healthcare Corporation	36000-012, 36000-013
Phenylephrine	Makes it, tests it, packages it, labels it and sterilizes it	Baxter Healthcare Corporation	36000-358, 36000-360, 36000-362
Propofol	Makes it, tests it, packages it, labels it and sterilizes it	Baxter Healthcare Corporation	36000-058
Sumatriptan	Makes it, tests it, packages it, labels it and sterilizes it	Baxter Healthcare Corporation	36000-289
Tobramycin	Makes it, tests it, packages it, labels it and sterilizes it	Baxter Healthcare Corporation	36000-242, 36000-244

FDA inspection history

Ended	Result	Program	Problems noted
Jan 27, 2023	Serious problems, FDA action	Drug Quality Assurance	9
May 17, 2022	Problems found, fixed voluntarily	Drug Quality Assurance	—
Aug 4, 2017	Serious problems, FDA action	Drug Quality Assurance	—
Aug 26, 2016	Problems found, fixed voluntarily	Drug Quality Assurance	—
May 11, 2015	Problems found, fixed voluntarily	Drug Quality Assurance	—
Oct 18, 2013	Problems found, fixed voluntarily	Drug Quality Assurance	—
Mar 2, 2012	Problems found, fixed voluntarily	Drug Quality Assurance	—
Jun 16, 2010	Serious problems, FDA action	Drug Quality Assurance	—
Nov 12, 2009	Problems found, fixed voluntarily	Drug Quality Assurance	—

What inspectors wrote down

From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.

Jan 27, 2023 inspection

Absence of Written Procedures 21 CFR 211.100(a)
Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess.
Procedures for sterile drug products 21 CFR 211.113(b)
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established.
Scientifically sound laboratory controls 21 CFR 211.160(b)
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.
Written procedures followed 21 CFR 211.186(a)
Procedures for the preparation of master production and control records are not followed.
In-Process and Laboratory Control Results 21 CFR 211.188(b)(5)
The batch production and control records are deficient in that they do not include in-process control results.
Investigations of discrepancies, failures 21 CFR 211.192
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
Equipment Design, Size and Location 21 CFR 211.63
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use and cleaning and maintenance.
Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
Written procedures not established/followed 21 CFR 211.67(b)
Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.

Registered with FDA for: analysis; label; manufacture; pack; sterilize.