FDA issues warning Letter to Verichem Laboratories

FDA has issued warning letter to Verichem Laboratories for manufacturing adulterated medical devices on February 4, 2015. Verichem Laboratories manufactures clinical chemistry reference materials like calibrators (Class 2 devices) and calibration verifiers (Class 1 devices) for in vitro diagnostic (IVD) use. During inspection Inspector noted the following violation in Form 483:

1.    Failure to establish and maintain procedures for validating device design.

2.    Failure to adequately maintain device master records

3.    Failure to establish and maintain procedures to control all required documents.

4.   Failure to ensure that all equipment used in the manufacturing process meets specified requirements and is appropriately designed, constructed, placed and installed to facilitate maintenance, adjustment,cleaning and use.

5.   Failure to establish procedures for quality audits and conduct such audits to assure that the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system.

6.    Failure to maintain device history records (DHR).

7.    Failure to establish and maintain procedures for acceptance of incoming product.

8.    Failure to maintain complaint files.

9.   Failure to establish and maintain procedures that describe the methods for authorizing the receipt from and dispatch  to storage areas and stock rooms

This information revealed that these devices are adulterated within the meaning of section 501(h) of the Act (21 U.S.C. § 351(h)). This inspection again confirmed Verichem nonconformity with the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation found at Title 21, Code of Federal Regulations (CFR), Part 820

FDA notified Verichem Laboratories to take corrective actions to prevent these violations and submit a written report to FDA which should include an explanation about Verichem planning to prevent these violation(s), or similar violation(s), from occurring again within 15 working days of receiving this letter. After 15 Days a follow-up inspection will be done by FDA to assure that corrections are adequate.