Drug factory · FDA FEI 1000208638

Gregory Pharmaceutical Holdings, Inc., dba UPM Pharmaceuticals

501 5th St, Bristol, TN, United States

Problems found, fixed voluntarily at FDA's last inspection, Sep 20, 2024.

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

12 drug inspections on record since 2008: 6 with no problems, 5 with problems fixed voluntarily, 1 with FDA action.

What it does, for whom

Drug	Role	For	NDC
Belumosudil	Makes it, tests it, packages it and labels it	Kadmon Pharmaceuticals, LLC	79802-200
Plecanatide	Makes it	Salix Pharmaceuticals, Inc.	65649-003

Ended	Result	Program	Problems noted
Sep 20, 2024	Problems found, fixed voluntarily	Drug Quality Assurance	5
Apr 12, 2019	Problems found, fixed voluntarily	Drug Quality Assurance	4
Oct 28, 2016	No problems found	Drug Quality Assurance	—
Aug 14, 2015	Problems found, fixed voluntarily	Drug Quality Assurance	—
Jun 11, 2014	Problems found, fixed voluntarily	Drug Quality Assurance	—
Nov 13, 2012	Problems found, fixed voluntarily	Drug Quality Assurance	—
Oct 26, 2012	No problems found	Drug Quality Assurance	—
Apr 8, 2011	No problems found	Drug Quality Assurance	—
Aug 30, 2010	No problems found	Drug Quality Assurance	—
Aug 9, 2010	No problems found	Drug Quality Assurance	—
Oct 27, 2008	No problems found	Drug Quality Assurance	—
Oct 27, 2008	Serious problems, FDA action	Drug Quality Assurance	—

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

Following/documenting laboratory controls 21 CFR 211.160(a)
Established laboratory control mechanisms are not followed.
Complaint Investigation/Follow-Up Findings 21 CFR 211.198(b)(2)
Complaint records are deficient in that they do not include the findings of the investigation.
Buildings not maintained in good state of repair 21 CFR 211.58
Buildings used in the of a drug product are not maintained in a good state of repair.
Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent malfunctions and contamination that would alter the safety, identity, strength, quality or purity of the drug product.
Written procedures fail to include 21 CFR 211.67(b)
Written procedures for cleaning and maintenance fail to include description in sufficient detail of methods, equipment and materials used.

Written procedures followed 21 CFR 211.186(a)
Procedures for the preparation of master production and control records are not followed.
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.
Calibration/Inspection/Checking not done 21 CFR 211.68(a)
Routine inspection and checking of automatic, mechanical and electronic equipment is not performed according to a written program designed to assure proper performance.
Handling and Storage to Prevent Contamination 21 CFR 211.80(b)
There was a failure to handle and store components at all times in a manner to prevent contamination.

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