Drug factory · FDA FEI 1000160734

PYRAMID Laboratories, Inc.

3598 Cadillac Ave., Costa Mesa, CA, United States

Problems found, fixed voluntarily at FDA's last inspection, Feb 13, 2026.

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

8 drug inspections on record since 2011: 3 with no problems, 5 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

Drug	Role	For	NDC
Glucagon	Makes it and tests it	American Regent, Inc.	0517-2901

Ended	Result	Program	Problems noted
Feb 13, 2026	Problems found, fixed voluntarily	Drug Quality Assurance	2
Sep 29, 2021	Problems found, fixed voluntarily	Drug Quality Assurance	5
Apr 2, 2018	No problems found	Drug Quality Assurance	—
Jun 5, 2015	Problems found, fixed voluntarily	Drug Quality Assurance	—
Jan 15, 2015	Problems found, fixed voluntarily	Drug Quality Assurance	—
Mar 28, 2013	No problems found	Drug Quality Assurance	—
Apr 26, 2012	No problems found	Drug Quality Assurance	—
Feb 4, 2011	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.

Investigations of discrepancies, failures 21 CFR 211.192
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
Equipment construction - reactive surfaces 21 CFR 211.65(a)
Equipment surfaces that contact components and in-process materials are reactive, additive or absorptive so as to alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements.

Lab controls established, including changes 21 CFR 211.160(a)
The establishment of laboratory control mechanisms including any changes thereto, are not reviewed and approved by the quality control unit.
In-process sample representation/identification 21 CFR 211.160(b)(2)
In-process samples are not representative.
Laboratory equipment calibration records 21 CFR 211.194(d)
Laboratory records do not include complete records of the periodic calibration of laboratory instruments.
Environmental Monitoring System 21 CFR 211.42(c)(10)(iv)
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
Computer control of master formula records 21 CFR 211.68(b)
Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.

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