FDA again slaps Indian API maker Unimark Remedies with warning letter over records, pests

FDA sign

The FDA, which has been on a campaign to get Indian drugmakers to conform with its regulations, slapped Unimark Remedies with another warning letter in which it cited two of the Mumbai-based drugmaker’s plants for keeping poor records, failing to train employees properly, and unsanitary conditions.

Last fall, the company was hit by a warning letter by the regulatory agency at a separate facility  for similar infractions, which included pigeon nests in the building and a lizard roaming in a controlled area.

In the most recent warning letter, during an inspection of the company’s Bavla facility in August 2015, FDA officials “observed dirt and birds in the manufacturing area as well as a lizard in the controlled processing area.” 

Whitepaper

Simplify and Accelerate Drug R&D With the MarkLogic Data Hub Service for Pharma R&D

Researchers are often unable to access the information they need. And, even when data does get consolidated, researchers find it difficult to sift through it all and make sense of it in order to confidently draw the right conclusions and share the right results. Discover how to quickly and easily find, synthesize, and share information—accelerating and improving R&D.

There was that at the site as well as a failure to adequately investigate and document out-of-specification results, ensure that test procedures are scientifically sound, and maintain training records for workers involved in the manufacture of intermediates or APIs.

Unimark’s Vapi facility, which was inspected in May 2015, was cited for failing to follow-up on out-of-specification results or evaluate the potential effect that changes in the manufacturing process may have on the quality of its APIs.

Poor-record keeping and unsanitary conditions have become a common theme of FDA warning letters to Indian drugmakers. The U.S. agency and regulators in Europe have dialed up their inspections in recent months and years, resulting in punishments for companies such as Wockhardt, Sun Pharma, Ranbaxy Labs and others.

According to a survey by Reuters last year, more than 40 drug production facilities in India have been banned by the FDA.

- check out the FDA warning letter

Related Articles:
Pests again figure into issues in FDA warning letter to Indian API maker 
FDA lambasts Sri Krishna Pharma plant in new warning letter 
Marksans the latest Indian drugmaker cited with noncompliance by European regulators
Anuh Pharma plant savaged in EMA report

Read more on

Suggested Articles

Three Samsung execs face up to two years in jail for their roles in destroying data and documents at under-fire affiliate Samsung BioLogics.

The FDA has slapped a U.S. drug repackager, saying in a warning letter that its storage processes and equipment cleaning are not up to expectations.

Higher operating costs were behind a 17% slide in pretax profits last year at Allergan’s Mayo, Ireland, facility that produces Botox.