Warning Letters Week Of 9/20/2020: Quality Unit Failures

Last week, FDA issued Warning Letters to two drug companies, one a repackager and the other a manufacturer of sunscreen, and two compounding pharmacies. Both drug Warning Letters cited issues with the Quality Unit while products were recalled from both compounding pharmacies.

Drug Warning and Untitled Letters

Coupler Enterprises

Coupler Enterprises (Warrington, PA) received a Warning Letter on September 15, 2020, based on the outcome of an inspection ending March 10, 2020. The firm repackages human drugs. Deficiencies include, but are not limited to:

• The investigators noted multiple different tablets and capsules in the packaging area. Documentation indicated that the line clearance had been performed. FDA is concerned about inadequate line clearance and the possibility of product mix-ups.
• The firm did not demonstrate that cleaning activities are sufficient to remove residues from equipment shared among drug products. The firm could provide no justification for those drug products used in cleaning validation studies. Although the firm has a consultant they could not explain progress in this area.
• The Quality Unit did not provide adequate oversight and FDA particularly mentioned the lack of adequacy in deviation investigations. The Quality Unit also failed to see that equipment was qualified.

HNC Product

HNC Product Inc. (Bloomington, IL) received a Warning Letter on September 10, 2020, based on the outcome of an inspection ending March 17, 2020. In addition to the adulteration violations, the firm failed to meet the registration and listing requirements in the FD&C Act. The firm manufactures sunscreens. FDA notes “Your quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture.” FDA adds their short version of the boilerplate they use for data integrity remediation requirements. FDA explains that the Quality Unit does not have adequate authority to exercise its authority and responsibilities and finally suggests the firm employ a qualified consultant to assist them in coming into GMP compliance. Deficiencies include but are not limited to: 

• OOS investigations are inadequate. The example noted that sample and standard preparation, root cause analysis conclusions, and corrective actions were missing. Further, the original data for the OOS had been overwritten (electronically) and were missing. The rationale for invalidating the result is not scientifically justified and did follow OOS procedure. 
• Manufacturing processes were not validated, nor was there an ongoing program for review process results. 
• The firm does not have an independent and effective Quality unit. Further, there is no change management or annual product review program. Further, bulk products are shipped outside of the firm’s control prior to receipt of final laboratory test results. 

Device Warning and Untitled Letters

There were none this week.

BIMO, GCP and GLP Warning and Untitled Letters

There were none this week.

Compounding Pharmacy / Outsourcing Facilities

First Royal Care Co LLC dba Red Mountain Compounding Pharmacy 

First Royal Care Co LLC dba Red Mountain Compounding Pharmacy (Mesa, AZ) received a Warning Letter on September 8, 2020, based on the outcome of an inspection ending June 14, 2019. FDA notes the firm agreed to recall all sterile human and animal drugs that are within expiry after the audit. In addition to adulteration violations, the firm also compounds and sells drugs the FDA deems to be misbranded.

Integrated Health Concepts Inc. dba Conversio Health

Integrated Health Concepts Inc. dba Conversio Health (San Luis Obispo, CA) received a Warning Letter on September 10, 2020, based on the outcome of an inspection ending September 25, 2019. FDA also notes the firm has recalled all sterile products within expiry three months after the end of the inspection and ceased sterile operations to permit implementation of improvement plans.