This week enforcement was busy with a GLP warning letter, warning letters to an API manufacturer and a pharmaceutical firm, a couple of compounding pharmacies, and a device firm.

  • PRECLINICAL GLP: American Preclinical Services (Minneapolis, MN) received a warning letter on February 12, 2019 based on the outcome of an inspection ending April 13, 2018. This warning letter corrects the one issued on October 4, 2018.
  • DISTRIBUTOR: Vipor Chemical Private Ltd (India) received a warning letter on January 29, 2019 based on the outcome of an inspection ending February 24, 2018. The firm makes APIs. The firm has not yet responded to the Form 483 observations. The firm was placed on import alert 66-40 on July 11, 2018. Further, they were placed on import 99-32 (refusing an FDA inspection) on October 10, 2017. The firm is also advised to hire GMP consultant(s) to assist them in coming into GMP compliance. Deficiencies include but are not limited to:
    • The firm omitted the name and address of the original API manufacturer on certificates of analysis issued to their customers.
    • The firm lacks base GMP procedures including those controlling issuance and reconciliation of batch manufacturing records. GMP information is recorded in personal notebooks or on draft batch records which are then transcribed onto another batch record which is circulated for signatures. Draft documents are ‘incinerated in a wood burner.’ The firm also asked the FDA investigation why this procedure was problematic. Further, the firm does not have procedures to investigate deviations, OOS results, OOT results and stability failures.
    • The equipment cleaning procedure used only water, and claimed that is what is commonly done in API firms. Also, equipment was observed with visibly encrusted black residue and rust.
  • DRUG: Hangzhou SunKing Nonwovens Co., Ltd (Hangzhou, China) received a warning letter on January 29, 2019 based on the outcome of an inspection ending August 9, 2018. The firm manufactures OTC drug products. The firm is also cited for what appears to be reliance on a contract laboratory for release decisions. The text really isn’t clear but we can assume that they aren’t assuming the responsibility but rather delegating it to their contractor. The firm was placed on import alert 66-40 on December 13, 2018. FDA also recommends that the firm hire consultant(s) to assist them in coming into compliance with CGMPs. Deficiencies include but are not limited to:
    • The firm released drug products without testing for identity of the active ingredient, among other attributes. FDA expressed concern about the validity of test results from their contract laboratory because some results were identical for multiple batches shipped to the US.
    • The firm did not test incoming raw materials but rather relied on the suppliers CoA without qualifying the supplier.  
    • The firm does not have an established stability program to ensure that expiry dates are supported by data.
    • The firm has not validated the manufacturing process, nor do they have an ongoing program to ensure stable manufacturing operations.
    • And last but not least, the firm does not have an adequate quality unit with procedures for basic GMP processes.
  • DEVICE: Datascope Corp. (Mahwah, NJ) received a warning letter on February 6, 2019 based on the outcome of an inspection ending October 3, 2018. The firm sells intra-aortic balloon pumps and IAB pumps. The company site in NJ received a warning letter in October 2018. In November 2018, FDA issued a warning to healthcare professionals and the following day issued a Class I recall. The Swiss Getinge Group purchased the firm in 2008. FDA proposes that the firm meet with FDA to discuss the issues raised this inspection. Deficiencies in this current warning letter include but are not limited to:
    • Design validation was not performed after a change to ensure it met user needs and intended use.
    • The CAPA program failed to identify all the actions needed to correct and prevent recurrence of non-conforming product.  
    • Suppliers were not selected on the basis of their ability to supply product that met specified requirements. The warning letter includes seven examples of failure to qualify suppliers and implement quality agreements.

COMPOUNDING PHARMACY WARNING LETTERS:

  • Bella Pharmaceuticals received a warning letter on February 11, 2019 based on the outcome of an inspection ending February 23, 2017.
  • United Pharmacy received a warning letter based on the outcome of an inspection ending August 18, 2017.

About the Author

Barbara W. Unger is Govzilla’s Quality Expert and Editor-in-Chief of GMP Regulatory Intelligence. She formed Unger Consulting, Inc. in December 2014 to provide GMP Quality consulting services to the pharmaceutical and biopharmaceutical industry. At Amgen, she led the segment of the Corporate GMP Audit group at Amgen focused on API manufacturers, Quality Systems and Computers. She developed, implemented and maintained the GMP Regulatory Intelligence program for 8 years at Amgen Inc. This included surveillance, analysis and communication of GMP related legislation, regulations, guidance and industry compliance enforcement trends. This was an essential service and tool within the Corporate Audit function. Unger Consulting Inc. | www.ungerconsulting.net | 805.217.9360