Drug factory · FDA FEI 2510480

Ems Acquisition Corp

701 Hemlock Rd, Morgantown, PA, United States

Problems found, fixed voluntarily at FDA's last inspection, Oct 24, 2025.

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

5 drug inspections on record since 2008: 1 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

Drug	Role	For	NDC
Salicylic Acid	Makes it	PruGen, Inc.	42546-279

Ended	Result	Program	Problems noted
Oct 24, 2025	Problems found, fixed voluntarily	Drug Quality Assurance	4
Jul 22, 2022	Problems found, fixed voluntarily	Drug Quality Assurance	1
Oct 22, 2015	Problems found, fixed voluntarily	Drug Quality Assurance	1
Jan 10, 2013	No problems found	Drug Quality Assurance	—
Nov 6, 2008	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.

Absence of Written Procedures 21 CFR 211.100(a)
Your firm failed to establish 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.
Microbiological testing 21 CFR 211.165(b)
Each batch of drug product required to be free of objectionable microorganisms is not tested through appropriate laboratory testing.
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.
Component identification test 21 CFR 211.84(d)(2)
Specific identification tests are not conducted on components that have been accepted based on the supplier's report of analysis.

Absence of Written Procedures 21 CFR 211.100(a)
There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess.

Absence of Written Procedures 21 CFR 211.100(a)
There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess.

Second person sign off 21 CFR 211.194(a)(8)
Laboratory records do not include the initials or signature of a second person showing that the original records have been reviewed for accuracy, completeness, and compliance with established standards.
Equipment Design, Size and Location 21 CFR 211.63
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use.

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