Posted FDA 483 Violations | Week of 10/21/18

It’s violation study time, and our GMP expert has extracted the key documents from this week’s global headlines. To note is Operation Pangea XI as well as Europe’s multiple reports of GMP non-compliance.


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  • Cipla Limited received a 1-page, 2-observation 483 at the close of the inspection on September 28th 2018. Observations include:
    • The commercial batch record does not include all instructions for significant steps in the process.
    • Investigations do not always include conclusions and follow up.


  • It’s that time of year again, Operation Pangea XI is in full swing with the goal of combating the unlawful sale and distribution of illegal and potentially counterfeit medical products sold on the internet. HERE is the FDA press release on their activities. And HERE is information from the HPRA. And HERE is the MHRA update on their activities.
  • Health Canada’s Inspection Tracker posted updates for the following firms:
    • Apotex Pharmaceuticals
    • Apotex Pvt. Ltd.
    • Bayer
    • B. Braun Medical
    • Beauty Manufacturing Solutions Corp.
    • Beijing Taiyang Pharmaceutical Industry Co. Ltd
    • Bend Research


  • A report of GMP non-compliance was issued to Mercury Laboratories Ltd in India by the health authorities of Malta based on an inspection ending August 26th 2018. Non-compliance was in the areas of non-sterile products, packaging, and Quality Control Testing. The authority identified 1 critical deficiency, 6 major deficiencies, and 13 other deficiencies.
    • The critical deficiency concerned authenticity of records which could not be verified including production records and quality risk assessment records. The major deficiencies were cited for highly deficient production activities, process validation that does not provide assurance that the medicinal product consistently produces a product meeting its specifications and quality attributes, deficient supplier approval systems, quality control and microbiology laboratory deficiencies, inadequate pharmaceutical quality system and documentation management and inadequate cleaning validation to ensure no cross contamination.”
    • This was the 1st inspection by the EU for the site, and, thus, there was no impact to product in the absence of a GMP certificate. The recommendations are that marketing authorization applications involving this site should not be considered.
  • A report of GMP non-compliance was issued regarding BioMedica Foscama Group S.P.A (Ferentino, Italy) based on the outcome of an inspection by the Italians Medicines Agency on October 10th 2018. The non-compliant operations included sterile products, packaging, and quality control testing. The nature of the non-compliance included:
    • “17 (seventeen) ‘Major’ and 1 (one) ‘Other’ deficiencies were found during the inspection. The ‘Major’ deficiencies were related to inadequate pharmaceutical quality system that resulted in the following issues: lack of environmental qualification of the aseptic manufacturing areas and a lack of qualification of critical equipments (e.g. autoclaves, depirogenation tunnels, lyophilisers, ampoules leak testing machines, filter integrity tester, visual inspection machines); QC equipment were not qualified and data integrity was not assured; batch release was executed without finalizing the batch record review; grade A continuity not adequately ensured for the protection of some materials used in the aseptic manufacturing area; poor deviations management and investigation.”
    • Supplies should be prohibited for use while the non-compliance remains in place. One API registration was suspended and 1 manufacturing authorization was suspended in full.
  • A report of GDP non-compliance was issued regarding Dialab spol. s.r.o. in the Czech Republic based on an inspection by the authorities of the Czech Republic. The firm failed to ensure the services of a qualified person.

Remember, the FDA posts just a fraction of the thousands of 483s they issue. In contrast, we have over 11,000 Form FDA 483s in our database that are keyword tagged, searchable, cross-referenced for easy comparison, and easy to copy/paste/print.


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About the Author

Barbara W. Unger is Govzilla’s Quality Expert and Editor-in-Chief of GMP Regulatory Intelligence.  She formed Unger Consulting, Inc. in December 2014 to provide GMP Quality consulting services to the pharmaceutical and biopharmaceutical industry.  At Amgen, she led the segment of the Corporate GMP Audit group at Amgen focused on API manufacturers, Quality Systems and Computers.  She developed, implemented and maintained the GMP Regulatory Intelligence program for 8 years at Amgen Inc.  This included surveillance, analysis and communication of GMP related legislation, regulations, guidance and industry compliance enforcement trends.  This was an essential service and tool within the Corporate Audit function.

Unger Consulting Inc. | | 805.217.9360

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