Drug factory · FDA FEI 3006419237

Piramal Pharma Solutions Inc.

1575 McGrathiana Pkwy, Lexington, KY, United States

Problems found, fixed voluntarily at FDA's last inspection, Dec 10, 2025.

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

8 drug inspections on record since 2009: 3 with no problems, 5 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

Drug	Role	For	NDC
Carmustine	Makes it	Navinta LLC	68475-503

Ended	Result	Program	Problems noted
Dec 10, 2025	Problems found, fixed voluntarily	Drug Quality Assurance	4
Jan 10, 2023	Problems found, fixed voluntarily	Drug Quality Assurance	—
Apr 11, 2019	No problems found	Drug Quality Assurance	—
Mar 14, 2018	Problems found, fixed voluntarily	Drug Quality Assurance	6
Apr 17, 2014	Problems found, fixed voluntarily	Drug Quality Assurance	—
Apr 15, 2014	No problems found	Drug Quality Assurance	—
Feb 27, 2009	Problems found, fixed voluntarily	Drug Quality Assurance	—
Feb 13, 2009	No problems found	Drug Quality Assurance	—

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

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 and followed.
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.
Computer control of master formula records 21 CFR 211.68(b)
Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.

Test methods 21 CFR 211.165(e)
The accuracy, sensitivity, specificity and reproducibility of test methods have not been established and documented.
Testing Calculations 21 CFR 211.194(a)(5)
Laboratory records are deficient in that they do not include all calculations performed during testing.
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.
Cleaning System 21 CFR 211.42(c)(10)(v)
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the equipment to produce aseptic conditions.
Computer control of master formula records 21 CFR 211.68(b)
Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.
Rejecting When Specifications Not Met 21 CFR 211.84(e)
Failure to reject any lot of components and drug product containers that did not meet the appropriate written specifications for identity, strength, quality, and purity.

Registered with FDA for: analysis; label; manufacture.