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Regulatory Focus™ > News Articles > 2019 > 12 > FDA Warns Two US Drugmakers Over GMP Deficiencies

FDA Warns Two US Drugmakers Over GMP Deficiencies

Posted 10 December 2019 | By Michael Mezher 

FDA Warns Two US Drugmakers Over GMP Deficiencies

The US Food and Drug Administration (FDA) recently warned two US-based drugmakers, Teligent Pharma in Buena, NJ, and OHM Pharma in Mineral Wells, TX, for good manufacturing practice (GMP) violations at their respective facilities.
Teligent Pharma
In its warning letter to Teligent Pharma, FDA cites the company for failing to thoroughly investigate out-of-specification (OOS) test results, inadequate stability testing practices, improper complaint handling and failing to submit field alert reports (FARs) for several of its products within the required timeframes following a month-long inspection last Spring.
According to FDA, Teligent failed to adequately investigate OOS test results for a lot of clobetasol propionate before releasing it in 2017. The same lot of clobetasol propionate also failed stability testing at nine- and 18-month intervals and in both cases, FDA says the company “took no market action.” The agency also says the company closed out investigations into OOS results for two lots of flurandrenolide ointment USP without proper justification.
Additionally, FDA says that Teligent failed to conduct stability tests within the timeframes set in the company’s written procedures for two other drugs, triamcinolone acetonide cream USP and Loprox (ciclopirox).
FDA also took issue with Teligent’s complaint handling practices, noting that more than half of the complaints it received in 2018 and 2019 were open for more than 30 days, with six remaining open for more than 150 days. FDA says the company failed to adequately review nearly 400 complaints about container closure issues.
OHM Pharma
FDA’s warning letter to OHM Pharma comes after a 10-day inspection in May that uncovered issues with the company’s cleaning practices, laboratory controls and manufacturing practices.
“You failed to adequately clean your facilities. Our investigator observed white residue in hallways and rooms within your production areas. These areas were identified as clean and were not in use at the time,” FDA writes.
FDA also takes the company to task for using “non-dedicated equipment and production areas to manufacture a wide variety of dietary supplements and drug products,” some of which “are produced from potentially toxic ingredients.”
Additionally, FDA says that OHM used scientifically unsound sampling and testing methods, including sampling and testing water that is not representative of what the company uses for manufacturing.
Warning Letters: Teligent Pharma, OHM Pharma

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