Drug factory · FDA FEI 1876582

King Pharmaceuticals LLC

1200 Parkdale Rd, Rochester, MI, United States

Serious problems, FDA action at FDA's last inspection, Feb 18, 2025.

Official Action Indicated: inspectors found significant problems and FDA recommended regulatory action, such as a warning letter or import alert.

11 drug inspections on record since 2008: 1 with no problems, 8 with problems fixed voluntarily, 2 with FDA action.

What it does, for whom

Drug	Role	For	NDC
Penicillin G	Makes it, tests it, packages it and labels it	Pfizer Laboratories Div Pfizer Inc	60793-600, 60793-601, 60793-602 +3

Ended	Result	Program	Problems noted
Feb 18, 2025	Serious problems, FDA action	Drug Quality Assurance	4
Oct 21, 2019	Problems found, fixed voluntarily	Drug Quality Assurance	1
Mar 14, 2018	No problems found	Drug Quality Assurance	—
Nov 21, 2016	Problems found, fixed voluntarily	Drug Quality Assurance	2
May 15, 2015	Problems found, fixed voluntarily	Drug Quality Assurance	1
Aug 26, 2014	Problems found, fixed voluntarily	Drug Quality Assurance	5
Dec 13, 2012	Problems found, fixed voluntarily	Drug Quality Assurance	6
Jun 15, 2012	Problems found, fixed voluntarily	Drug Quality Assurance	2
Mar 16, 2011	Problems found, fixed voluntarily	Drug Quality Assurance	9
Jan 19, 2010	Serious problems, FDA action	Drug Quality Assurance	10
Nov 25, 2008	Problems found, fixed voluntarily	Drug Quality Assurance	1

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

Control procedures to monitor and validate performance 21 CFR 211.110(a)
Control procedures are not established which monitor the output and validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.
Procedures for sterile drug products 21 CFR 211.113(b)
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and 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.
Approve or reject components, products 21 CFR 211.22(a)
The quality control unit lacks the responsibility and authority to approve and reject all in process materials.

Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not fully followed.

Establishment of time limitations 21 CFR 211.111
Time limits are not established when appropriate for the completion of each production phase to assure the quality of the drug product.
Written Procedures Not Followed 21 CFR 211.80(a)
Written procedures are not followed for the receipt, identification, storage, handling and approval of components and drug product containers.

Procedures for sterile drug products 21 CFR 211.113(b)
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not written and followed.

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