Pan Drugs Limited Receives FDA Warning Letter
FDA issued a warning letter to Pan Drugs Limited on August 25,
2016 following an inspection of the company’s Vadodara, India facility that
occurred from Nov. 30–Dec. 3, 2015. The company was cited for violations of
current good manufacturing practices (CGMPs) that included inadequate quality
control, unsanitary conditions, and improper control over computer systems. The
company was placed on Import Alert 66-40 by FDA on Dec. 8, 2015.
Quality concerns
According to FDA, adulterated API manufactured at the company’s
Nandesari facility, which was put on an FDA import alert on May 5, 2015, was
used in the manufacture of product shipped to the US market from Oct. 7—Nov.
23, 2015. The company’s quality unit also approved certificates of analysis
(COA) for product before conducting all quality control and release testing.
The warning letter stated that the “production manager falsified the documents
by signing and dating the ‘Prepared By’ and ‘Checked By’ sections of the COA.”
FDA stated, “According to your response, you recognized that these practices
were not adequate. You intended to implement a signature list and revise your
SOPs to address these failures. However, these actions do not address the
quality unit failures observed.”
Furthermore, the company’s facilities were found to be inadequately
maintained. Investigators were told that the company did not have cleaning
procedures for the equipment or facility. Mold-like substances on the walls of
processing areas and gaps and holes in walls where pests and vermin might enter
were found. A lizard was observed by inspectors in the facility and evidence of
other pest activity was seen. Rust, dirt, and lubrication leaks were observed
on shared drug manufacturing equipment.
FDA asked the company to “provide details of the plan you stated
you will develop for facility upgrades and corrections, including photographic
evidence that demonstrates that the entire facility meets CGMP requirements.
Your response should also include your plan to ensure your facility and
equipment will be proactively maintained in such a way that your product is
continually manufactured under CGMP conditions.”
Data integrity failures
In addition to the quality issues, FDA found that the company had
inappropriate control over computer and related systems. Unauthorized personnel
had access to master production and control records. FDA stated the company
should perform a comprehensive investigation of the inaccuracies in data
records and reporting that includes a detailed investigation of protocol and
methodology; interviews with current and former employees; an assessment of the
extent of data integrity deficiencies; and a comprehensive retrospective
evaluation of the nature of data integrity deficiencies.
FDA stated the company should also perform a current risk
assessment of the potential effects of the observed quality failures that
should include an analysis of patient risk. The agency asked the company to
provide a global corrective action and preventive action plan (CAPA) that
includes steps for ensuring relability and completeness of all data;
description of root causes of data integrity lapses; actions taken to ensure
quality of drugs; long-term measures describing remediation efforts and enhancement
of all procedures and processes; and a status report of all CAPA activities.
In addition to the data integrity and quality issues, the company
also attempted to delay FDA’s inspection and did not provide the agency with
all requested records, which is cause to consider the drugs as adulterated. In
the letter, FDA stated, “On November 30, 2015, our investigator observed your
warehouse supervisor tearing out pages from your firm’s annual report and
placing the pages into his pocket. Eventually, the supervisor provided the
pages to our investigator. On December 1, 2015, our investigator requested
printed chromatograms from your HPLC and GC. You failed to provide them.”
FDA stated in the letter that it may refuse admission of the
company’s products manufactured at the facility if the violations are not
corrected. FDA may also withhold approval of new applications or supplements
listing the company as a drug product manufacturer.
Source: FDA
(This story has not been edited by GMP Violations staff and is auto-generated from a syndicated feed.)
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