Drug factory · FDA FEI 3013791804

VKT Pharma Private Limited

Survey No. 21 to 27, Derasam Village, Srikakulam, India

Problems found, fixed voluntarily at FDA's last inspection, Feb 7, 2025.

Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.

2 drug inspections on record since 2020: 0 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

Drug	Role	For	NDC
Amlodipine	Makes it, tests it and packages it	Ascend Laboratories, LLC	67877-197, 67877-198, 67877-199
Escitalopram	Makes it	Torrent Pharma, Inc.	13668-135, 13668-136, 13668-137
Famotidine	Makes it, tests it, packages it and labels it	Ascend Laboratories, LLC	67877-842, 67877-843, 67877-889
Gabapentin	Makes it, tests it and packages it	Ascend Laboratories, LLC	67877-428, 67877-429
Lamotrigine	Makes it	Torrent Pharma, Inc.	13668-045, 13668-047, 13668-048 +1
Levetiracetam	Makes it, tests it, packages it and labels it	Rising Pharma Holdings, Inc.	64980-604, 64980-605, 64980-606 +1
Ranitidine	Makes it, tests it, packages it and labels it	Atland Pharmaceuticals, LLC, Rising Pharma Holdings, Inc., VKT Pharma Private Limited	71993-314, 71993-315, 64980-636 +3
Ranolazine	Makes it, tests it, packages it and labels it	Torrent Pharma, Inc.	13668-759, 13668-760
Sumatriptan	Makes it, tests it, packages it and labels it	Rising Pharma Holdings, Inc.	64980-660, 64980-661, 64980-662
Tadalafil	Makes it, tests it and packages it	Burel Pharmaceuticals, LLC, VKT Pharma Private Limited	35573-460, 35573-461, 35573-462 +5

Ended	Result	Program	Problems noted
Feb 7, 2025	Problems found, fixed voluntarily	Drug Quality Assurance	1
Feb 28, 2020	Problems found, fixed voluntarily	Drug Quality Assurance	2

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

Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.

Written record of investigation incomplete 21 CFR 211.192
Written records of investigations into unexplained discrepancies do not always include the conclusions and follow-up.
Written procedures not established/followed 21 CFR 211.67(b)
Written procedures are not followed 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.