Warning Letter Roundup: Firms in India, Lithuania and Texas Draw Warnings

December 29, 2017

Facilities in India, Lithuania and Texas drew warnings from the FDA for a variety of noncompliances, including inadequate device history records.

GPC Medical: The FDA warned an Indian devicemaker for noncompliances relating to process validation, device acceptance and labeling.

The agency inspected a GPC Medical facility in New Delhi in June of 2017 and found that the firm failed to ensure process corrections would be performed because it did not provide a plan for such corrections or any documentation supporting the corrections. The company also did not properly document finished device sampling procedures.

While the completed product testing plan indicated 100 percent inspection for dimensional acceptance, the product testing report deviated from this plan without any documented justification. The firm’s response to the agency’s Form 483 report, the firm said it would make corrections but failed to include a plan or documentation.

The company also did not include label accountability in its device history records or a copy of each size of label within a batch. The records only included a copy of the label in a single size. Again, the company’s response to the FDA observation only included assurances the corrections would be made rather than a detailed plan or documentation.

Telemed: Lithuanian device manufacturer Telemed landed an FDA warning letter when it failed to satisfy the agency with responses to problems identified during a July-August inspection.

In its inspection of the Vilnius facility, the agency found that the firm lacked an adequate design plan for its 2013-2015 MicrUS ultrasound imaging system.

In its response, the firm acknowledged the design plan template should comply with revised design control procedures, but it did not say how it would correct the issues or provide a design plan procedure for the FDA to review.

The company also did not implement adequate design verification features. It promised the agency to provide design verification procedures and a description of how each action would be implemented, but failed to do so. The firm did not establish proper design transfer procedures to describe how the design was translated into product specifications.

The warning letter also faulted the facility for its complaint procedures, which did not include elements required for an investigation record, including a definition of what is considered a complaint or a medical device reporting determination. A review of 12 complaint records between April 2016 and May 2017 found no MDR determinations for any complaints or any reply to the complainant.

Nurse Assist: Nurse Assist, a Texas-based manufacturer of sterile IV saline flush syringes, failed to maintain adequate device history records, perform CAPA actions or control labeling activities, according to an FDA warning letter.

An FDA site inspection, conducted less than two weeks after the firm began recalling some lots in October 2016 over reports of B. cepacia infections, revealed that several cases of its IV saline syringes had not been sterilized. Also, the device history records for the recalled lots did not include the final quantity of products reviewed, approved and released for distribution.

The firm’s CAPA actions were inadequate in that out-of-specification endotoxin test results for its water and saline distributed product lots were not investigated. The company also failed to investigate bioburden samples from some lots that exceeded the action limits in testing instructions, the agency said.

A December 2016 response to the Form 483 observations and a January incident report submitted by the firm did not fully address the issues. The company did not inform the FDA whether it had taken or planned to take corrective action to “ensure accountability of the labels used, rejected, or returned to storage for all medical device products.”

The agency requested a certification from a third party expert consultant for an audit of the firm’s manufacturing and quality assurance systems.

Read the GPC Medical warning letter here: www.fdanews.com/12-28-17-GPC.pdf.

Read the Telemed warning letter can be read here: www.fdanews.com/12-28-17-Telemed.pdf.

Read the Nurse Assist warning letter here: www.fdanews.com/12-22-17-NurseAssist.pdf. — Zack Budryk, Ana Mulero

What the FDA Wants to See in a Device History Record

The point of the device history record is to document that you carried out—accurately and completely—the activities and specifications recorded in the device master record.

“So the device master record is the recipe,” and the DHR “is the objective evidence that you followed the recipe,” says consultant Dan O’Leary, president of Ombu Enterprises.

The five items listed in 21 CFR Part 820.184 are the minimum requirements for the DHR:

  • Dates of Manufacture of the Finished Device – This is not just the date a device is complete and ready for market. When the regulation says “finished device” it means a device that is capable of working but may not yet be distributable.
  • Quantity Manufactured – This is the total number of that particular device that you produced, which is not necessarily the same as the next item.
  • Quantity Released for Distribution – The quantity manufactured minus the quantity released should equal the quantity of product left in inventory.
  • Acceptance Records – The data needed to complete this part of the DHR will be found in the records you kept in order to comply with section 820.80.
  • Labels and Labeling – The regulation requires only the primary identification label and labeling to be included in the DHR.
  • Identification and Control Numbers.

Excerpted from the FDAnews management report: Device Documentation — A Guide to Managing Four Critical Production Files.