Texas drug manufacturer smacked with FDA warning letter over multiple violations
A Texas drug manufacturing facility has drawn the FDA’s ire over missing records, inadequate processes and faulty controls on a laundry list of infractions outlined in an agency warning letter.
Fort Worth-based Monarch PCM, which makes pharmaceutical liquids, tablets, creams and lotions among other products, was inspected by the FDA from June through August last year. The new FDA warning letter dated June 10, 2022, listed the company’s methods, facilities and controls for a range of manufacturing and processing issues that did not conform to current good manufacturing practices (CGMP).
The warning letter contained several violations that particularly concerned the FDA, starting with the company failing to investigate any unexplained discrepancies or batch failures.
The FDA maintains that the company failed to adequately investigate out of specification (OOS) results for both drug components and finished drug products, invalidating microbial results due to limited and inadequate investigations. The company also failed to thoroughly investigate multiple out-of-limit microbial results in both old and new water systems. Additionally, the company did not address potential root causes as numerous aqueous-based drug products were manufactured and released during a period from 2019 to 2021.
The company failed to extend microbial contamination investigations to other potentially impacted drug products, the letter adds.
Another major issue? Monarch failed to use appropriately designed and sized equipment in the manufacture or processing of drug products. Specifically, its water systems and manufacturing equipment were not designed, cleaned and maintained appropriately with the FDA noting several infractions specific to the water issues.
The company responded by incorporating a new water system performance qualification protocol and developing a plan to execute the new protocol, but the responses were not sufficient for the FDA.
The company’s quality control unit also failed to responsibly ensure drug products manufactured were following CGMP standards, the FDA charges. The FDA inspectors, for instance, found testing for Burkholderia cepacia complex (BCC or B. cepacia) was not performed as required per established specifications, batch production records were not being established and CGMP records were missing prior to the investigation.
The company also failed to establish and follow a properly written testing program designed to assess the stability characteristics of drug products.
The FDA letter says a failure to address the matters can result in regulatory or legal action including seizures or an injunction. Unresolved violations may also prevent other federal agencies from awarding contracts. The FDA can also withhold the issuance of export certificates or the approval of new applications.
The company was given 15 days from the June 10th issue date to respond to the letter.
Monarch did not respond to an inquiry from Endpoints News by press time.