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

UsernamePublicRestriction
UsernamePublicRestriction

Ohm Labs violations draw warning letter

This article was originally published in The Tan Sheet

Executive Summary

FDA sends a follow-up warning letter to Ohm Laboratories regarding several good manufacturing practice violations. The agency identified the violations during a July and August 2009 inspection of the company's Gloversville, N.Y., facility. The OTC manufacturer, a subsidiary of Indian pharma Ranbaxy, insufficiently addressed the violations in a Sept. 11 letter, the agency said in its Dec. 21 warning. Specifically, the company's methods, facilities or controls used to manufacture, process, pack and/or hold products do not conform to GMP regs. For example, the firm failed to identify a conclusive root cause for the contamination of several products and did not extend the investigation into batches of similarly treated products. FDA seeks an immediate response from Ohm or else it will seek legal action. Ohm acknowledged receiving the initial warning in a Dec. 24 statement (1"The Tan Sheet" Jan. 11, 2010, In Brief)

You may also be interested in...



FDA warns Ranbaxy U.S. unit

Ohm Labs' liquid manufacturing plant in Gloversville, N.Y., draws an FDA warning letter for good manufacturing practice deviations. The subsidiary of Indian pharma Ranbaxy acknowledged receiving the letter in a Dec. 24 release, adding the GMP violations were discovered during FDA inspections in July and August 2009. FDA found two other U.S. Ohm plants compliant during 2009 inspections, the North Brunswick, N.J., firm said. Ohm sells and distributes private-label and OTC products in the U.S

Did Sarepta Need To Tell Investors About Its Vyondys 53 Dispute Resolution Request?

Attorneys say Sarepta did not have an obligation to report its appeal, particularly since winning a formal dispute filing with the US FDA is a long shot.

Sarepta’s Vyondys: Renal Toxicity Concerns That Delayed Approval Get Enhanced Postmarketing Scrutiny, Label Warning

Sarepta must perform enhanced pharmacovigilance for serious renal toxicity events and rhabdomyolysis with the Duchenne muscular dystrophy drug, which carries a label warning for renal toxicity. Approval letter includes 2024 target completion date for ESSENCE confirmatory trial.

Topics

UsernamePublicRestriction

Register

PS103782

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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

Cancel