> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Multiple Violations in Spectrum Laboratory Inspection
- URL: https://www.fdaweb.com/multiple-violations-in-spectrum-laboratory-inspection/
- Published: 2019-06-11T12:00:00.000Z
- Updated: 2026-09-15T01:32:05.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144307

An 11/8-11/16/18 FDA inspection at Spectrum Laboratory Products, Gardena, CA, found CGMP and other violations in the firm’s manufacturing of active pharmaceutical ingredients (API). A 6/4 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/spectrum-laboratory-products-573311-06042019?ref=fdaweb.com) says the CGMP violations were: 

- failing to transfer all quality or regulatory information received from the API manufacturer to Spectrum’s customers; and
- failure of the quality unit to ensure that critical deviations are investigated and resolved.

The letter also says Spectrum commercially distributes acetylcysteine, doxylamine, pyrimethamine, tamoxifen, and trichlormethiazide. None of those drugs are listed on the FDA drug listing database as required by regulations, the agency says. Also, it says, Spectrum’s fentanyl citrate, hydrocodone bitartrate, buprenorphine hydrochloride, hydromorphone hydrochloride, morphine sulfate, and nalbuphine hydrochloride API are misbranded.

The product list collected during the inspection, FDA says, included glycerin. The letter says use of glycerin contaminated with diethylene glycol has resulted in various poisoning incidents of humans worldwide.

FDA recommends that the company engage a qualified consultant to assist it in meeting CGMP requirements.

Spectrum was told to respond with a list of specific steps taken since the inspection to correct the deviations and prevent their recurrence, with a schedule for completion.