Drug factory · FDA FEI 3008953516

Bostal LLC

18 Mayfield Avenue, Edison, NJ, United States

Problems found, fixed voluntarily at FDA's last inspection, Dec 4, 2024.

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

7 drug inspections on record since 2011: 1 with no problems, 6 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

Drug	Role	For	NDC
Darifenacin	Makes it, tests it, packages it and labels it	Xiromed, LLC.	70700-182, 70700-183
Delafloxacin	Makes it and tests it	Melinta Therapeutics, LLC	70842-101, 70842-102
Fenofibric Acid	Makes it	Bostal LLC	35561-343, 35561-344
Tadalafil	Makes it	Bostal LLC	35561-254, 35561-255, 35561-256 +1

Ended	Result	Program	Problems noted
Dec 4, 2024	Problems found, fixed voluntarily	Bioresearch Monitoring	3
Apr 5, 2023	Problems found, fixed voluntarily	Drug Quality Assurance	2
Jan 5, 2018	Problems found, fixed voluntarily	Drug Quality Assurance	2
May 25, 2016	Problems found, fixed voluntarily	Drug Quality Assurance	—
Dec 18, 2013	Problems found, fixed voluntarily	Drug Quality Assurance	—
Jun 5, 2012	Problems found, fixed voluntarily	Drug Quality Assurance	—
Jun 3, 2011	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.

Failure to develop written procedures 21 CFR 314.80(b)
Written procedures have not been developed for the surveillance, receipt, evaluation and reporting to FDA of post marketing adverse drug experiences.
Late submission of annual safety reports 21 CFR 314.80(c)(2)
Not all annual periodic adverse drug experience reports have been submitted within 60 days of the anniversary date of the approval of the application.
Late submission of quarterly safety reports 21 CFR 314.80(c)(2)
Not all quarterly periodic adverse drug experience reports have been submitted within 30 days of the close of the quarter.

Establishment of calibration procedures 21 CFR 211.160(b)(4)
Procedures describing the calibration of instruments, apparatus, gauges and recording devices are not written or followed.
Training--operations, GMPs, written procedures 21 CFR 211.25(a)
Employees are not given training in the particular operations they perform as part of their function.

Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
Equipment and utensils are not maintained at appropriate intervals to prevent malfunctions and 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 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; manufacture.