NECC Preliminary Investigation Report 10/23/12

Excerpt from Preliminary Investigation Report:

SELECTED PRELIMINARY FINDINGS

During the facility inspections, investigators documented serious health and safety deficiencies related to the practice of pharmacy. All pertain to violations of 247 CMR 9.01(3) or 247 CMR 6.01(5)(a):

• NECC distributed large batches of compounded sterile products directly to facilities apparently for general use rather than requiring a prescription for an individual patient.
  

• Records show that NECC had lists of potential patient names but did not have patient-specific prescriptions from an authorized practitioner when compounding and dispensing medication, as required by state law.

• Manufacturing and distributing sterile products in bulk was not allowed under the terms of its state pharmacy license. If NECC was appropriately licensed as a manufacturer with the FDA the company would have been subject to additional levels of scrutiny.

• NECC did not conduct patient-specific medication history and drug utilization reviews as required by regulations.

• NECC distributed two of the recalled lots of methylprednisolone acetate (PF) 80 MG/ML prior to receiving results of sterility testing:
  

• Lot 06292012@26 was prepared on June 29, 2012. Final sterility testing was completed on July 17, 2012. Two shipments of product were made prior to the final sterility tests results being received.

• Lot 08102012@51 was prepared on August 10, 2012. Final sterility testing was completed on August 28, 2012. Eleven shipments of product were made prior to the final sterility tests results being received.

• While NECC’s records show the sterility tests found no contamination, the adequacy of NECC’s sterility testing methods are currently under examination.

• Final sterilization of product did not follow proper standards for autoclaving (sterilization through high pressure steam) pursuant to United States Pharmacopeia Standard 797 (USP 797) and NECC’s own Standard Operating Procedures:
  

• Examination of NECC records indicated a systemic failure to keep products in the autoclave for the required minimum 20-minute sterilization period necessary to ensure product sterility.

• NECC did not conduct proper validation of autoclaves pursuant to USP 797:
  

• NECC failed to test their autoclaves to ensure proper function.

• Visible black particulate matter was seen in several recalled sealed vials of methylprednisolone acetate from Lot 08102012@51.
  
  
• Powder hoods, intended to protect pharmacists from inhaling substances during medication preparation, within the sterile compounding area were not thoroughly cleaned pursuant to USP 797.
  

• Residual powder was visually observed within the hood during inspection. This contamination may subsequently lead to contamination of compounded medications.

• Condition of “Tacky” mats, which are used to trap dirt, dust, and other potential contaminants from shoes prior to clean room entry, violated the USP 797.
  

• Mats were visibly soiled with assorted debris.

• A leaking boiler adjacent to the requisite clean room created an environment susceptible to contaminant growth:
  

• A pool of water was visually observed around the boiler and adjacent walls, creating an unsanitary condition; the culture results of this potential contaminant are still pending.

  The full report (9 page PDF) is available at:
  
  NECC Preliminary Investigation Report, 10/23/12