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Regulatory Focus™ > News Articles > 2019 > 11 > FDA Warns Three Drugmakers, Diagnostic Company

FDA Warns Three Drugmakers, Diagnostic Company

Posted 19 November 2019 | By Michael Mezher 

FDA Warns Three Drugmakers, Diagnostic Company

The US Food and Drug Administration (FDA) recently warned three drugmakers for good manufacturing practice (GMP) violations and a California-based diagnostic maker for distributing reagents without submitting premarket notification or obtaining premarket approval for the tests.
Torrent Pharma
In its warning letter to Torrent Pharma, FDA cites the company for sanitary deficiencies related to its water system and for failing to thoroughly investigate failed test results for drugs manufactured at its Levittown, Pennsylvania facility following a month-long inspection in March and April.
According to FDA, a water system at the facility “was not adequately designed, controlled, maintained and monitored to ensure it consistently produced water that met … specifications and appropriate microbial limits.”
FDA says the company identified its water system as the source of Burkholderia cepacian that was isolated from other equipment samples. The water system had been used to manufacture rectal suppositories, oral solutions and nasal solutions.
While Torrent told FDA it will decommission the water system and use a temporary system until a new one is ready, the agency says the company failed to provide sufficient evidence that the temporary system would meet quality standards.
FDA also says Torrent’s water testing methods were “inadequate to reliably detect the presence of B. cepacia,” and that the company failed to extend investigations into microbial contamination to all potentially affected batches of drugs.
Additionally, FDA cites the company for manufacturing two misbranded and unapproved new drugs, phenobarbital oral solution, USP and hydrocortisone acetate suppositories, 25mg. According to the agency, neither drug is subject to an approved new drug application (NDA) and they are misbranded, as the drugs do not bear adequate directions for use.
Apothecus Pharmaceutical
FDA warned Apothecus Pharma over inadequate investigations into failed test results and complaints for products made by a contract manufacturer.
According to FDA, the company received a complaint on one of it its batches of vaginal contraceptive foam, reporting “leakage and missing or illegible codes on containers.”
FDA says the company’s investigation into the complaint was inadequate as it was not expanded to other batches of the foam that could have been impacted. While the company told FDA it would recall the affected batches, FDA says it has not yet received notice of a recall.
The agency also cites the company for not having sufficient controls over its high-performance liquid chromatography (HPLC) system “to prohibit deletion of data, and to prevent alteration of data without appropriate documentation and justification,” and says the data for the system was stored on a single computer and had not been backed up.
A.P. Deauville
FDA’s warning letter to New Brunswick, New Jersey-based drugmaker A.P. Deauville comes after a lengthy inspection in April and May and cites the company for insufficient investigations, lacking quality unit oversight and inadequate manufacturing controls.
According to FDA, the company “failed to investigate multiple failures of [its] water system to meet chemical and microbial limits,” after a contract laboratory reported out-of-limit results for microbial total plate count for the system.
FDA also says the company failed to adequately investigate complaints of possible allergic reactions to its over-the-counter topical drugs.
Additionally, the agency says A.P. Deauville’s quality unit failed to identify and investigate manufacturing deviations and that the company lacked an “ongoing program for monitoring process control to ensure stable manufacturing operations.”
Carolina Liquid Chemistries
FDA’s warning letter to Brea, CA-based Carolina Liquid Chemistries cites the company for manufacturing and distributing Class I and II in vitro diagnostic reagents without submitting a premarket notification or obtaining premarket approval for the devices.
Specifically, FDA says the company manufactured and distributed reagent devices for Tapentadol, Zolpidem and Fentanyl testing that were labeled “for forensic use only” or “for research and development use only” to pain management centers and a clinical testing laboratory.
FDA says the is no evidence that the reagents are used by the firms they were sold to solely for forensic or research and development purposes.
As such, FDA says the reagents are adulterated and misbranded.
Warning Letters: Torrent, Apothecus Pharmaceutical, A.P. Deauville, Carolina Liquid Chemistries

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