Regulatory Focus™ > News Articles > 2021 > 3 > FDA warns Florida firm for GMP, QS violations

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Posted 30 March 2021 | By Michael Mezher 

FDA warns Florida firm for GMP, QS violations

2737 In a lengthy warning letter issued to Tarmac Products, Inc, a Florida-based contract manufacturer, the US Food and Drug Administration (FDA) cites the company for a dozen good manufacturing practice (GMP) and quality system (QS) violations.
The warning letter, first published Tuesday, was sent last November based on issues observed during a two-and-a-half-week inspection in September 2019, several of which are repeat observations from previous inspections in 2015 and 2017.
In addition to the GMP and QS violations, FDA also cites the company for marketing an unapproved new drug. FDA says the product in question, an antiperspirant marketed under the name Hypercare, does not meet the labeling and formulation requirements of the agency’s 2003 final rule for OTC antiperspirant products.
GMP violations
Among the five GMP violations cited in the warning letter, FDA calls Tarmac out for failing to ensure laboratory records include complete data, failing to thoroughly inspect out-of-specification (OOS) test results and failing to follow a written testing program to assess drug stability.
In a repeat issue from the 2015 and 2017 inspections, FDA says Tarmac employees are still overwriting original test results so that only the passing result appears in the audit trail for the company’s BioLumix microbiological testing system.
FDA also charged the company for failing to adequately investigate assay failures for its OTC bisacodyl suppository products. “You failed to investigate the root cause and identify and perform CAPA [corrective and preventive action) for assay failure in bisacodyl suppository lot 261. Also, you did not open investigations for assay failures in bisacodyl lots 491 and 511,” FDA writes.
In another repeat issue, FDA says the company was missing stability data for an OTC pain relief product to demonstrate quality through expiry. “Your response stated that the tests were performed and reported but not placed in the final report and approved,” FDA writes.
Additionally, FDA cites the company for failing to routinely calibrate, inspect or check equipment and for failing to establish adequate laboratory controls. The agency notes that the company’s BioLumix equipment had failing fluorescent light calibration results in samples from 2019 and that its microbiological test methods were deficient.
QS violations
The warning letter also cites Tarmac for seven medical device QS violations, most of which relate to two wound dressing products the company manufacturers.
FDA says the company did not adequately qualify a system used in the manufacture of the two wound dressing products and failed to establish procedures to control product that does not conform to specified requirements. Both citations note that the company retested failed samples and only documented the passing results.
In two other citations, FDA says the company failed to perform certain microbiological tests for its Sonafine wound dressing according to its stability protocol and failed to validate design changes to a raw material used to manufacture Sonafine and Venelex Ointment wound dressing.
FDA also dings the company for failing to ensure equipment meets specified requirements and for failing to take remedial action after multiple failed calibrations of the Biolumix system.
Lastly, FDA cites Tarmac for failing to establish and maintain CAPA procedures. “Your firm’s CAPA procedure … does not include the requirements for analyzing quality data, including but not limited to out-of-specifications (OOSs), deviations, investigations, complaints, internal and external audits, returned product, rework, production operations, and environmental and cleaning control records, to identify existing and potential causes of nonconforming product, or other quality problems, using appropriate statistical methodology where necessary,” FDA writes.


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