Drug factory · FDA FEI 3002806521

Mylan Teoranta

Inverin, Co. Galway, Ireland

Problems found, fixed voluntarily at FDA's last inspection, Jul 15, 2022.

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 2009: 3 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

Drug	Role	For	NDC
Ketamine	Makes it, tests it, packages it and labels it	AuroMedics Pharma LLC	55150-438, 55150-439, 55150-440 +1
Sotalol	Makes it	ALTATHERA Pharmaceuticals, LLC	69724-112

Ended	Result	Program	Problems noted
Jul 15, 2022	Problems found, fixed voluntarily	Drug Quality Assurance	—
Jun 22, 2018	Problems found, fixed voluntarily	Drug Quality Assurance	—
Feb 16, 2018	Problems found, fixed voluntarily	Drug Quality Assurance	2
Jun 15, 2016	No problems found	Drug Quality Assurance	—
May 27, 2014	Problems found, fixed voluntarily	Drug Quality Assurance	4
Mar 30, 2012	No problems found	Drug Quality Assurance	—
Oct 15, 2009	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.

Inadequate number of personnel 21 CFR 211.25(c)
The number of qualified personnel is inadequate to supervise the manufacture and processing of each drug product.
Sanitation--buildings not clean, free of infestation 21 CFR 211.56(a)
Buildings used in the manufacture, processing, packing or holding of drug products are not maintained in a clean and sanitary condition.

Written in-process control procedures 21 CFR 211.110(a)
Written procedures are not established that describe the examinations to be conducted on appropriate samples of in-process materials of each batch.
Lab controls established, including changes 21 CFR 211.160(a)
The establishment of specifications, standards, and test procedures including any changes thereto, are not drafted by the appropriate organizational unit.
Test methods 21 CFR 211.165(e)
The reproducibility of test methods have not been established and documented.
Contamination, chemical or physical change, deterioration 21 CFR 314.81(b)(1)(ii)
An NDA-Field Alert Report was not submitted within three working days of receipt of information concerning in a distributed drug product.

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