Ampac Fine Chemicals, a Rancho Cordova, California pharmaceutical contract manufacturer now owned by SK Holdings, has been the subject of multiple lawsuits and government enforcement actions. The Ampac Fine Chemicals lawsuits and regulatory cases on record cover employee wage claims in California and Virginia, an FDA warning letter over contaminated cancer-drug manufacturing, an EPA hazardous waste penalty, and a string of OSHA citations tied to chemical exposure incidents at the Rancho Cordova plant.
Employment Lawsuits Filed Against Ampac
Bussey v. AMPAC Fine Chemicals Virginia (2024)
D’Andre Bussey, Jesse Cave, and Christopher Dale Markham sued AMPAC Fine Chemicals Virginia, LLC in the U.S. District Court for the Eastern District of Virginia (Case No. 3:24-cv-00881) under the Fair Labor Standards Act. On June 23, 2025, District Judge Henry E. Hudson approved the settlement agreement, calling it “fair, reasonable, and adequate,” and approved $13,500 in attorneys’ fees and litigation costs. All claims were dismissed with prejudice.1PACER Monitor. Bussey et al v. AMPAC Fine Chemicals Virginia, LLC et al
Bell v. AMPAC Fine Chemicals (2021)
Stephanie Bell, Michele D. Mason, and Marzena Noren filed a labor and employment lawsuit in February 2021 in Sacramento County Superior Court against Ampac Fine Chemicals LLC, Fine Chemicals Holdings Corp, and SK Pharmteco Inc. Ampac moved to compel arbitration in April 2021. The parties filed a notice of settlement on February 10, 2023, and the plaintiffs requested dismissal on February 23, 2023.2UniCourt. Stephanie Bell vs. AMPAC Fine Chemicals LLC
Overtime Misclassification Class Action (2015)
A March 2015 class action filed in Sacramento County Superior Court (Case No. 34-2015-00175993) alleged that Ampac misclassified its Associate Chemists as exempt from overtime pay. The complaint said these chemists cleaned and maintained instruments, managed inventory, ordered chemicals, and performed analytical testing, and did not supervise other employees. The suit alleged they were denied overtime wages and mandatory meal and rest breaks under California labor law.3PR Web. Sacramento Employment Law Lawyers Sue Ampac Fine Chemicals The available record does not show a publicly reported outcome.
FDA Warning Letter Over Contaminated Cancer Drug Manufacturing
The FDA issued Ampac a warning letter in June 2010 after a February 2010 inspection of the Rancho Cordova facility turned up several violations of Current Good Manufacturing Practice regulations for active pharmaceutical ingredients.4GMP Navigator. FDA Warning Letter – AMPAC Fine Chemicals
The most serious findings involved manufacturing of temozolomide, a cancer drug ingredient. Inspectors documented dirt, rust, blistering paint, and oil near production equipment. In January 2009, paint chips fell into a reactor during a charging step and contaminated a batch that had to be rejected. Inspectors also found the company had failed to properly document cleaning of major equipment between different product batches. In one instance, a room was released for production without cleaning, while paperwork falsely stated the room was clean and that logs were complete. A drum of returned temozolomide was stored alongside approved material with no label indicating its status.4GMP Navigator. FDA Warning Letter – AMPAC Fine Chemicals
The FDA rejected Ampac’s written response as inadequate, saying the company failed to describe specific contamination controls, dismissed a cleaning lapse as an “isolated incident” without explaining how it would prevent recurrence, and did not address how it would manage returned materials going forward.5Fierce Pharma. FDA Calls Out AMPAC on Sketchy Reply to Warning The agency warned that continued failure to correct the problems could lead to product seizure, injunctions, and withholding of approval for pending drug applications listing the facility.4GMP Navigator. FDA Warning Letter – AMPAC Fine Chemicals
EPA Penalty for Hazardous Waste Violations
In November 2022, the EPA announced a settlement requiring Ampac to pay $69,879 for violations of the Resource Conservation and Recovery Act and related California hazardous waste laws at Rancho Cordova. The violations were identified during a February 2020 EPA inspection.6U.S. EPA. EPA Penalizes Ampac Fine Chemicals Resolving Claims Hazardous Waste Law Violations
Inspectors found that Ampac had not performed required calibration testing, had failed to mark equipment subject to air emission standards for leaks, and lacked a monitoring plan for valves that were difficult or unsafe to inspect. Incompatible hazardous wastes were not properly separated during accumulation, and hazardous waste containers were not correctly labeled. A qualified professional engineer had not assessed the integrity of an existing tank, and the facility’s contingency plan did not list emergency equipment capabilities. The settlement resolved all claims tied to these findings.6U.S. EPA. EPA Penalizes Ampac Fine Chemicals Resolving Claims Hazardous Waste Law Violations
OSHA Citations and Worker Chemical Exposures
The Rancho Cordova facility has drawn multiple OSHA inspections tied to chemical incidents.
On December 3, 2013, an inexperienced, newly certified forklift operator punctured a 265-gallon tote of waste chemicals, creating a chlorobenzene vapor plume. Seven employees were sent to a hospital for inhalation and respiratory exposure and released within a few hours without restrictions.7OSHA. Inspection Detail – 316524230 OSHA characterized the cause as “misjudgment of a hazardous situation.”8OSHA. Accident Investigation Detail
In July 2016, a small leak of anhydrous hydrogen bromide from a cylinder on the Aerojet Rocketdyne campus where Ampac operates triggered a Level 3 hazmat response and evacuation of non-essential personnel.9Rancho Cordova Independent. Level 3 Hazmat in Rancho Cordova A separate OSHA inspection opened in December 2016 produced four violations, one serious and three other-than-serious, with initial penalties of $20,625. A June 2017 formal settlement reduced the penalties to $7,875.10OSHA. Inspection Detail – 1198752.015
On March 26, 2019, three employees were exposed to hydrogen chloride vapors. OSHA opened an inspection two days later and cited the company for 14 violations, five serious and nine other-than-serious, with initial penalties of $67,055. An informal settlement deleted several citations and reduced the final penalty to $3,190. The case closed in November 2019.11OSHA. Inspection Detail – 1389864.015
An earlier OSHA inspection opened in September 2008 and closed in March 2010 produced 10 violations and penalties totaling $24,175.12OSHA. Inspection Detail – 311071005
California Emergency Permit for Reactive Chemicals
In May 2021, the California Department of Toxic Substances Control issued Ampac an emergency permit to treat expired, potentially reactive chemicals onsite at Rancho Cordova. The DTSC determined the chemicals posed an “imminent and substantial endangerment to human health and the environment” and were unsafe to transport. They included peroxide-forming materials such as ethyl ether, methyl tert-butyl ether, and tetrahydrofuran, along with the temperature-sensitive compound Diazald. Clean Harbors Environmental Services stabilized the materials. The permit ran from April 29 through June 29, 2021.13California DTSC. Ampac Fine Chemicals Emergency Permit Public Notice