Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By



Executive Summary

TESTPAK REPACKAGING OF ORAL SOLID DOSAGE DRUGS DRAWS WARNING LETTER from FDA's Newark, N.J. district office on Nov. 10. The letter followed an inspection of TestPak's Whippany, N.J. facility on Oct. 4, 5 and 13. The investigators found that TestPak "lacks appropriate documentation supporting the expiration dates applied to products repackaged into either unit dose or multi-dose packages." "Without the appropriate documentation," the letter states, TestPak is "required to do stability studies to support the expiration dates." Furthermore, the investigation found, "documentation is not kept showing retained samples are examined at least yearly for evidence of deterioration." TestPak responded to FDA on Nov. 24, saying it would get the necessary documentation from the manufacturers. The company said Dec. 1 that all other points addressed in the warning letter were answered to FDA's satisfaction. The agency letter also cites TestPak's failure "to retain a reserve sample for each repackaging operation" and censured the company for "not [following] its own [standard operating procedures] regarding label count discrepancies." The investigators also found TestPak's record-keeping procedures "inadequate," pointing out that: "obliteration of information was noted in various documents without identification of the person blanking out the information"; "record entries are not made as procedures occur"; and "labeling inventory control records are not completed." In addition, the letter states: "The Quality Assurance review of batch records prior to product release does not include all production records associated with production of the batch." Finally, FDA said TestPak did not include "the review of all packaging records" in its follow-up investigation of a mislabeling complaint.

You may also be interested in...

Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data

Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011

FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance

FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials

Shire Hopes To Sow Future Deals With $50M Venture Fund

Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth




Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts