Drug factory · FDA FEI 3009078927

Osmotica Pharmaceutical US LLC

895 Sawyer Rd, Marietta, GA, United States

Problems found, fixed voluntarily at FDA's last inspection, May 2, 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 2013: 2 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

Drug	Role	For	NDC
Methylphenidate	Makes it	Golden State Medical Supply, Inc.	51407-924, 51407-925, 51407-926 +1

Ended	Result	Program	Problems noted
May 2, 2025	Problems found, fixed voluntarily	Drug Quality Assurance	6
Aug 7, 2019	No problems found	Drug Quality Assurance	—
Jan 18, 2019	Problems found, fixed voluntarily	Drug Quality Assurance	1
Nov 12, 2015	No problems found	Drug Quality Assurance	—
Apr 26, 2013	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.

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.
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.
Complaint Handling Procedure 21 CFR 211.198(a)
Procedures describing the handling of written and oral complaints related to drug products are deficiently written or followed.
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.
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.
Written procedures fail to include 21 CFR 211.67(b)
Written procedures for cleaning and maintenance fail to include maintenance and cleaning schedules and instructions for protection of clean equipment from contamination prior to use.

GMP Training Frequency 21 CFR 211.25(a)
GMP training is not conducted on a continuing basis to assure that employees remain familiar with CGMP requirements applicable to them.

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