QA/QC

Darmerica recalls API lots due to label mix-up

19-Sep-2019 By Vassia Barba

Darmerica recalls two lots of product labeled as quinacrine, a compound used as a sclerosing agent, which were instead found to contain a treatment for malaria.

UPDATED

FDA delivers warning to Chinese company after no response to Form 483

10-Sep-2019 By Ben Hargreaves

US FDA sends a warning letter to Yino, after the company failed to provide a response to issues raised in a Form 483 regarding relabeling of API.

Shilpa Medicare facility suffers 3 power cuts in 15 minutes, receives Form 483

02-Sep-2019 By Ben Hargreaves

The US FDA issues a Form 483 to Shilpa Medicare, after an investigation noted five observations that require action, including an unreliable power supply.

Analysis finds bulk of warnings delivered to Indian and Chinese drugmakers

30-Aug-2019 By Ben Hargreaves

The US market is dependent upon API and generic drugs produced in India and China, yet these countries also received the majority of warning letters issued by the US FDA.

FDA makes example out of Chinese OTC manufacturer

23-Aug-2019 By Ben Hargreaves

The FDA posted a public missive alongside a warning letter to a Chinese OTC drug manufacturer, highlighting the efforts it had been making to address data integrity issues.

Natco Pharma API facility receives Form 483

12-Aug-2019 By Vassia Barba

US FDA issues another Form 483 with six observations to Natco Pharma, noting procedural discrepancies.

Jubilant recalls lot of potentially ineffective contraceptives

06-Aug-2019 By Vassia Barba

Jubilant voluntarily recalls one lot of contraceptive tablets due to out-of-specification dissolution results, potentially decreasing efficacy.

FDA issues second Form 483 on Dr Reddy’s India plant

05-Aug-2019 By Vassia Barba

Dr Reddy’s receives a Form 483 with five observations, regarding customer complaints for out-of-specifications results of APIs.

July roundup: Regulators experience a busy month

31-Jul-2019 By Ben Hargreaves

July has seen a number of actions taken by regulators to manage the supply of medicine, including a crackdown on CBD manufacturers and repackers of opioid medication.

Biohaven’s application rejected due to Apotex manufacturing issues

22-Jul-2019 By Ben Hargreaves

Biohaven’s sublingual Riluzole treatment for ALS receives a CRL from the US FDA due to the API being supplied by Apotex.

FDA finds cGMP documents in Strides’ scrap yard

18-Jul-2019 By Ben Hargreaves

In a warning letter, the US FDA details how its inspectors discovered cGMP document awaiting shredding and records discarded in a 55-gallon drum at Strides’ facility.

Warning letter and Form 483 received by Indoco made public

16-Jul-2019 By Ben Hargreaves

Indoco confirms receipt of a warning letter from the US FDA and the agency posts details of a Form 483 for two different facilities in the space of one week.

Akorn’s warning letter reveals 'inadequate' investigations into manufacturing issues

11-Jul-2019 By Ben Hargreaves

The US FDA published another warning letter sent to Akorn, which details cases of improper investigation into faulty batches, failure to exercise controls over data, and ‘poor aseptic behaviour’.

Novel manufacturing technologies ‘fit poorly’ into regulatory models, says EMA

05-Jul-2019 By Ben Hargreaves

The EMA looks to the future by posting its five key priorities to address in the coming five years, which includes the need to recruit expertise in ‘novel manufacturing technologies’.

Altaire recalls more than 20 products due to ‘management concerns’

04-Jul-2019 By Ben Hargreaves

Altaire instigates voluntary recall of sterile ophthalmic treatments, after concerns were raised about QA processes in place at its manufacturing facility.

FDA-EMA mutual recognition: Germany in, one country left

02-Jul-2019 By Vassia Barba

With Germany’s addition to the US FDA-EMA mutual recognition agreement, only Slovakia is left to be added to the agreement, with the deadline later this month.

Piramal expands high potency API facility in Michigan

27-Jun-2019 By Vassia Barba

Piramal’s $10m expansion at its site in Michigan supports ‘dramatic growth’ and ‘brings more to the table’.

Sun Pharma hit with Form 483 after eight-year wait on design plan

24-Jun-2019 By Ben Hargreaves

US FDA delivers a Form 483 with four observations to Sun Pharma, with one noting that the company took eight years to create design plans for the production of one product.

Pharmacy detects ‘high levels’ of new carcinogen in valsartan batches

20-Jun-2019 By Ben Hargreaves

Valisure detects fourth probable carcinogen in valsartan medication and criticises the US FDA’s daily exposure limits as lacking a ‘rational basis’ and being ‘of significant concern’.

FDA to ‘institutionalize’ compounding regulation to ‘protect consumers’

19-Jun-2019 By Nick Taylor

The US FDA is set to center its drug compounding regulatory program in an office focused on stopping poor quality, unsafe and ineffective drugs reaching patients.

NEWS IN BRIEF

Paracetamol batches recalled after fungal contamination

18-Jun-2019 By Ben Hargreaves

The MHRA announces recall of paracetamol tablets, after certain products were found to be discoloured due to the presence of fungi.

FDA discloses third Form 483 to Aurobindo during 2019

13-Jun-2019 By Ben Hargreaves

Aurobindo has received another Form 483 from the US FDA, after the agency found its response to complaints were ‘not always sound’ for products destined for the US market.

Cambrex completes $11m labs and logistics center expansion

11-Jun-2019 By Vassia Barba

Cambrex announces the completion of a 600-square-meter facility in Karlskoga, Sweden, alongside a 3,000-square-meter warehouse.

Heritage issues recall after products contaminated with ‘microbial growth’

27-May-2019 By Ben Hargreaves

Heritage announces a recall of lots of amikacin sulfate injection and prochlorperazine edisylate injection, due to evidence of selected products being non-sterile.

Lupin receives Form 483 after product contaminated with human hair

23-May-2019 By Ben Hargreaves

US FDA issues Lupin with a Form 483 based on three observations during a recent inspection at its Aurangabad site.

Par recalls product after glass particulate contamination

13-May-2019 By Ben Hargreaves

Par Pharmaceutical initiates a recall of mycophenolate mofetil injection, after a vial containing a glass fragment was discovered during reconstitution.

Mylan announces quarterly loss due to Morgantown restructuring

13-May-2019 By Vassia Barba

Troubleshooting in Mylan’s Morgantown facility, after a US FDA warning, has hurt the company’s first quarter results.

Brexit on the agenda of ‘every meeting’ for EMA during 2018

10-May-2019 By Ben Hargreaves

In its full-year report, the EMA revealed the impact that Brexit had on the agency, including staff numbers and reduced operating capacity.

Torrent hit with two plant observations in three weeks

06-May-2019 By Ben Hargreaves

The Indian company announced that the US FDA issued observations for both its Indrad and Dahej facilities, as well as being required to expand its losartan recall.

Waves of sartan recalls lead to new FDA draft guidance

01-May-2019 By Ben Hargreaves

The US FDA has issued draft guidance on the process of voluntary recalls, after a series of recalls involving sartan contamination with carcinogenic impurities.

Aurobindo hit with Form 483 containing 11 observations

11-Apr-2019 By Ben Hargreaves

An observation by the US FDA notes that Aurobindo had no established control procedures to monitor its manufacturing process, resulting in batches contaminated with unidentified material.

UPDATED

GSK and AZ partner with CPI for continuous manufacturing facility

08-Apr-2019 By Ben Hargreaves

UK pharma giants, GSK and AstraZeneca, collaborate with CPI to build a continuous wet granulation manufacturing facility for oral solid dosage drugs.

Long-standing issues result in warning letter for Teva

12-Mar-2019 By Ben Hargreaves

Repeat observations for Teva’s facility results in US FDA issue warning letter, citing ‘inadequate oversight and control by executive management’.

Akorn receives good news after manufacturing network blow

05-Mar-2019 By Ben Hargreaves

Akorn announces fraud case launched by Fresenius has been denied by US courts, shortly after fourth quarter financials revealed problems within its manufacturing network.

Two more EU countries added to US mutual recognition project

19-Feb-2019 By Ben Hargreaves

Poland and Slovenia have confirmed their place as EU member states deemed capable of carrying out GMP inspections at an equivalent level to the US.

POLL

FDA seeks transparent relationship on manufacturing standards

15-Feb-2019 By Ben Hargreaves

US FDA is reaching out to the industry to agree upon ‘voluntary consensus standards’ to promote the development of drugs and reduce manufacturing cost.