FDA uncovers shredding of documents at Strides; Indoco gets another warning letter

FDA uncovers shredding of documents at Strides; Indoco gets another warning letter

By PharmaCompass

2019-07-18Impressions: 103

FDA uncovers shredding of documents at Strides; Indoco gets another warning letter

India saw flagrant violations of current good manufacturing practices (cGMP) yet again. An FDA inspection of Strides Pharma Science Limited uncovered uncontrolled shredding of documents along with discarded cGMP documents. The finished pharmaceutical manufacturing site located in Periyakalapet, Puducherry, was inspected from January 28 to February 5, 2019.

The FDA investigator found multiple bags of uncontrolled cGMP documents, which were awaiting shredding, with color coding indicating they were from drug production, quality, and laboratory operations. A blue binder containing cGMP records, including discarded batch records for US drug products, was also found along with other records in a 55-gallon drum in Strides’ scrapyard. The dates on the cGMP documents in the binder indicate they were only seven days old, when the FDA inspection took place.

The warning letter issued to Strides questions the effectiveness of its Quality Unit, the integrity and accuracy of the firm’s cGMP records along with the firm’s ability to thoroughly investigate deviations.

In its response to the FDA, Strides stated that the binder of cGMP documents “inadvertently come [sic] to scrap yard” and that they were investigating the issue.

Indoco Remedies’ unit receives FDA warning letter: There was more bad news from India — Indoco Remedies received a warning letter for its tablet manufacturing operations. The company’s sterile injectable manufacturing facility had received a warning letter in March 2017, but was cleared by the FDA in April.

In February, PharmaCompass had reported that data-integrity concerns had been uncovered at the firm’s tablet manufacturing facility (Plant I) in Goa. Following a seven-day inspection in January, the FDA had issued a Form 483 to the company, which had revealed data-integrity concerns. The investigation “found that production and IPQA (in-process quality assurance) personnel purposely recorded values within established limits” even though the actual values were not within limits.

Last year, the same Indoco facility was cited by the UK's Medicines and Healthcare products Regulatory Agency (MHRA) for GMP non-compliance after inspectors found “evidence of falsification of data in GMP records”.

The inspection, which was conducted in March 2018, had also found that the company’s pharmaceutical quality system was ineffective and the firm provided false and misleading statements to the inspectors.

The consistency of inspection outcomes at Indoco comes at a time when the FDA announced that after five years of close cooperation with the EU, the FDA has successfully completed its capability assessments of 28 EU member states. The assessments have determined that each EU member state has the capability, capacity and procedures in place to carry out cGMP inspections at a level equivalent to the US.

This process will help the FDA mutually recognize inspections conducted by EU member states and reduce its inspection burden when it comes to covering 4,600-plus registered establishments subject to surveillance inspections, three-fifths of which are on foreign soil.

The EU had completed its capability assessment about the FDA in June 2017.

The PharmaCompass Newsletter – Sign Up, Stay Ahead

Feedback, help us to improve. Click here

Image Credit : #Phisper Infographic by SCORR MARKETING & PharmaCompass is licensed under CC BY 2.0

“ The article is based on the information available in public and which the author believes to be true. The author is not disseminating any information, which the author believes or knows, is confidential or in conflict with the privacy of any person. The views expressed or information supplied through this article is mere opinion and observation of the author. The author does not intend to defame, insult or, cause loss or damage to anyone, in any manner, through this article.”

DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.

Our Latest Blogs

  1. Pharma & Biotech Newsmakers in Feb 2024

    By Pharmacompass

    March 07, 2024

  2. FDA Tackles Challenges Faced by CGTs

    By Pharmacompass

    February 22, 2024

  3. Pharma & Biotech Newsmakers in Jan 2024

    By Pharmacompass

    February 08, 2024

 

LinkedIn Twitter