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# CGMP Issues at Syntec Pharma
- URL: https://www.fdaweb.com/cgmp-issues-at-syntec-pharma/
- Published: 2021-08-03T12:00:00.000Z
- Updated: 2026-09-14T17:08:56.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149846

A 10/7-10/28/20 FDA inspection at Syntec Pharma, Farmingdale, NY, found significant deviations from current good manufacturing practice (CGMP) for active pharmaceutical ingredients (API). A just-released 7/6 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/syntec-pharma-corp-612765-07062021?ref=fdaweb.com) identifies the deviations as: 

- failing to perform repackaging, relabeling, or holding of API under appropriate CGMP to avoid mix-ups and loss of API identity or purity;
- failing to adequately establish written procedures for cleaning equipment and its release for use in the manufacture of API and validate written procedures for the cleaning and maintenance of equipment; and
- failure of the firm’s quality unit to exercise its responsibility to ensure that API manufactured at the facility comply with CGMP.

The letter also notes that all drug products of three of the company’s API suppliers were subject to an import alert at the time Syntec imported drugs from the firms. FDA says it also has issued Warning Letters to two of Syntec’s API suppliers explaining that issues related to CGMP compliance cause the drugs to be adulterated.

FDA recommends that the firm engage a qualified consultant to thoroughly evaluate its entire operations to assist it in meeting CGMP requirements. The agency acknowledges Syntec’s decision to suspend the manufacturing of drugs at the Farmingdale facility.

Syntec was told to correct all deviations promptly and to respond with a list of specific actions it has taken since the inspection to correct the deviations and prevent their recurrence, with a schedule for completing the actions.