Drug factory · FDA FEI 1824909

Future Pak LLC

28115 Lakeview Drive, Wixom, MI, United States

Problems found, fixed voluntarily at FDA's last inspection, Oct 15, 2024.

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 2010: 1 with no problems, 7 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

Drug	Role	For	NDC
Carvedilol	Labels it	Waylis Therapeutics LLC	80725-383, 80725-385, 80725-387 +1

Ended	Result	Program	Problems noted
Oct 15, 2024	Problems found, fixed voluntarily	Drug Quality Assurance	6
Dec 12, 2019	Problems found, fixed voluntarily	Drug Quality Assurance	—
Jan 11, 2018	Problems found, fixed voluntarily	Drug Quality Assurance	2
Dec 7, 2016	No problems found	Drug Quality Assurance	—
Aug 5, 2015	Problems found, fixed voluntarily	Drug Quality Assurance	5
Feb 7, 2013	Problems found, fixed voluntarily	Drug Quality Assurance	2
May 5, 2011	Problems found, fixed voluntarily	Drug Quality Assurance	2
Mar 10, 2010	Problems found, fixed voluntarily	Drug Quality Assurance	—

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

SOPs not followed / documented 21 CFR 211.100(b)
Written production and process control procedures are not followed in the execution of production and process control functions.
Written in-process control procedures 21 CFR 211.110(a)
Written procedures are not established and followed that describe the in-process controls to be conducted on appropriate samples of in-process materials of each batch.
Following/documenting laboratory controls 21 CFR 211.160(a)
Established specifications, sampling plans and test procedures are not followed.
Investigations of discrepancies, failures 21 CFR 211.192
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
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 procedures not established/followed 21 CFR 211.67(b)
Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.

Procedure Deviations Recorded and Justified 21 CFR 211.100(b)
Deviations from written production and process control procedures are not recorded.
Calibration/Inspection/Checking not done 21 CFR 211.68(a)
Routine calibration of equipment is not performed according to a written program designed to assure proper performance.

Master manufacturing record-specifications; packaged, label 21 CFR 111.205(b)(1)
Your master manufacturing record did not identify specifications for the points, steps, or stages in the manufacturing process where control is necessary to ensure that the dietary supplement is packaged and labeled as specified in the master manufacturing record.
Review of representative number of batches 21 CFR 211.180(e)(1)
Written procedures are not established for evaluations conducted at least annually to review records associated with a representative number of batches, whether approved or rejected.
Written record of investigation incomplete 21 CFR 211.192
Written records of investigations into unexplained discrepancies and the failure of a batch or any of its components to meet specifications do not always include the conclusions and follow-up.
Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not fully followed.
Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
Equipment and utensils are not cleaned at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.

Annual visual exams of drug products 21 CFR 211.170(b)
Reserve samples from representative sample lots or batches of drug products selected by acceptable statistical procedures are not examined visually at least once a year for evidence of deterioration.
Habits of good sanitation & health 21 CFR 211.28(b)
Production personnel were not practicing good sanitation and health habits.

Registered with FDA for: label; manufacture; pack; repack.