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# Ecometics Inspection CGMP Violations
- URL: https://www.fdaweb.com/ecometics-inspection-cgmp-violations/
- Published: 2019-07-16T12:00:00.000Z
- Updated: 2026-09-15T01:38:08.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144540

An 8/17-9/7/18 FDA inspection at the Ecometics drug manufacturing facility in Norwalk, CT, found significant repeat violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A just-released 4/16 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/ecometics-inc-569167-04162019?ref=fdaweb.com) says specific violations were: 

- failing to establish and follow adequate written procedures for cleaning and maintaining equipment;
- failing to conduct, for each batch of drug product, appropriate laboratory testing as necessary, required to be free of objectionable microorganisms;
- failing to use equipment in the manufacturing, processing, packing, or holding of drug products that is of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and for its cleaning and maintenance; and
- failing to follow an adequate written testing program designed to assess drug product stability characteristics.

The letter says the company is a contract manufacturer for over-the-counter and prescription drug products, and reminds Ecometics that it is responsible for the quality of drugs it produces as a contract facility, regardless of any agreement in place with the product owners.

FDA found similar violations in a 9/2016 inspection, the letter says, and the company at that time proposed specific remediations. “Repeated failures demonstrate that executive management oversight and control over the manufacture of drugs is inadequate,” the agency says.

The letter says FDA recommends that the firm engage a qualified consultant to assist it in meeting CGMP requirements.

The agency also notes that Ecometics failed to submit drug listing information to FDA for many of the drugs it manufactures. In addition, it says, the company is distributing one or more unapproved prescription drugs.

Ecometics was told to correct the violations promptly and to respond to the Warning Letter with a list of specific steps taken since the inspection to correct the violations and prevent their recurrence, with a schedule for completion.