Texas Pharmaceutical Company Hit With 483 For Missing Records and Inadequate Processes
July 12th, 2022 // 12:54 pm @ jmpickett
A Texas drug manufacturer received a 483 on June 10, 2022 for missing records, inadequate processes and inappropriate controls as well as other CGMP violations.
The company is Monarch PCM and it’s based in Fort Worth. The facility manufactures tablets, liquids, lotions and creams, and was audited by FDA between June and August 2021. The FDA warning letter stated that the firm’s facilities, controls, and methods for many processing and manufacturing issues didn’t conform to cGMP practices.
The most significant concern in the letter was that the company didn’t investigate unexplained batch failures and discrepancies. FDA also noted the company didn’t investigate OOS results for finished drug components and drug components. This issue led to microbial results being invalidated because of inadequate and limited investigations.
The company also did not investigate several out of limit microbial results in new and old water systems. Also, the firm didn’t look at possible root causes as several aqueous based drug products were made and released between 2019 and 2021.
Monarch also did not extend microbial contamination investigations to other possibly affected drug products. Next, the firm didn’t use properly designed and sized equipment for the processing and manufacture of drug products. For example, water systems and manufacturing equipment were improperly cleaned, designed, and maintained. FDA noted several problems related to the water problems.
Next, Monarch’s QC unit didn’t responsibly ensure that drug products they made followed cGMP guidelines. FDA found that company testing for BCC and B. cepacia wasn’t performed according to speficiations. And batch production records were not established. cGMP records also were not available before the investigation.
