Drug factory · FDA FEI 1130591

Aphena Pharma Solutions - Maryland, LLC

7978 Industrial Park Road, Easton, MD, United States

Problems found, fixed voluntarily at FDA's last inspection, Feb 20, 2026.

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

6 drug inspections on record since 2011: 1 with no problems, 5 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

Drug	Role	For	NDC
Glycopyrronium	Makes it	Journey Medical Corporation	69489-411

Ended	Result	Program	Problems noted
Feb 20, 2026	Problems found, fixed voluntarily	Drug Quality Assurance	3
Dec 15, 2021	Problems found, fixed voluntarily	Drug Quality Assurance	—
Sep 10, 2015	No problems found	Drug Quality Assurance	—
Jun 27, 2013	Problems found, fixed voluntarily	Drug Quality Assurance	4
Jan 13, 2012	Problems found, fixed voluntarily	Drug Quality Assurance	3
Jan 5, 2011	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.

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.
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.
Procedures To Be in Writing 21 CFR 211.80(a)
Written procedures are lacking which describe in sufficient detail the receipt, testing, approval and rejection of components and drug product containers.

Printing devices 21 CFR 211.122(h)
Printing devices used to imprint labeling upon the drug product unit label and case are not monitored to assure that all imprinting conforms to the print specified in the batch production record.
Valid stability test methods 21 CFR 211.166(a)(3)
The written stability program for drug products does not include reliable and specific test methods.
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.
Stability testing records not included 21 CFR 211.194(e)
Laboratory records do not include complete records of all stability testing performed.

Training , Education , Experience overall 21 CFR 211.25(a)
Employees engaged in the manufacture of a drug product lack the training required to perform their assigned functions.
Lack of or inadequate procedures 21 CFR 820.100(a)
Procedures for corrective and preventive action have not been adequately established.
Documentation 21 CFR 820.100(b)
Corrective and preventive action activities and/or results have not been adequately documented.

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