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Warning letters, 483s, Recalls, Import Alerts, Audit observations
Warning letters, 483s, Recalls, Import Alerts, Audit observations
The USFDA has placed Dabur’s Dadra and Nager Haveli facility under Import Alert 66-40 in June 2026. This action follows an inspection in January 2026 by FDA Investigator Rafeeq A. Habeeb, which revealed serious violations of fundamental cGMP requirements — spanning data integrity, falsification of records, inadequate laboratory controls, microbiological testing, cleaning validation, batch review and release, facility maintenance, and product quality reviews.
The FDA 483 flagged fundamental violations of GMPs highlighting lack of review and exercise of authority of Quality control unit.
During the inspection, microbiology test plates were found to have countable colonies including Too Numerous To Count (TNTC) plates, but the historical data for microbiology testing of finished products were reporting 100% of the time zero colonies (<10 CFU). Obviously the observations raised concerns that the past data may not be representing actual results. Apart from that the test documents also showed repetitive number patterns. The 483 observed the Quality unit failed to identify or investigate complete absence of microbiology OOS results over past five years.
Several sample analysis testing plates of finished products scheduled for reading as per analytical data note book were missing with no documentation of disposal. Other lapses observed included lack of second person verification for microbiology plates reading and growth promotion tests were only performed only once on receipt of media and not for every batch of prepared media used in testing.
Discrepancies were found in residue on ignition and melting range tests, pH and viscosity test data between BMR, COA and analytical note books and there were no analytical test procedures, test sheets or work books supporting the test results reported on COA. Equipment log book entries were also missing for melting range, pH tests, viscometer usage.
Stability program was in adequate and failed to maintain a complete inventory of stability samples and procedures for reviewing stability data.
The Firm was depending on visual inspection for cleaning verification. Acceptance criteria are limited to visual appearance and there was no scientifically established maximum allowable carry over limits (MACO). Sampling strategy was also found deficient with deficiencies in identification of worst case locations; sampling did not include direct surface sampling and difficult to clean areas. A cleaning validation performed for a single product production line was extended to other multi product lines with no scientific justification.
Serious data integrity violations were also observed with the manufacturing records and equipment logs falsified to misrepresent a multi-product manufacturing line as single product line and no cleaning validation was performed
Batch manufacturing records (BMRs) had errors including incorrect documentation of API quantity used and missing signatures by Chemists and QA personnel on cleaning and sanitation checklists and inprocess test data sheets. It was also observed critical process parameters and equipment identification numbers were not recorded consistently in BMRs. Production and process controls were deficient, and process validation studies were not completed for all products.
It was also found that finished product inspection results were initially being recorded on loose papers before transferring to official log notebooks. Also in finished product inspections actual number of product boxes opened were falsified claiming more product units tested than were sampled. And no deviation investigations were initiated after discovering critical defects.
Firm also failed to perform Annual Product Quality Reviews (APQRs) for the majority of products manufactured at the site.
Buildings and facilities used for manufacturing and storage of drug products were not maintained in a clean and sanitary condition with citing of live bird and bird droppings in the raw material warehouse which was not very far from where packing material were stored. Also the warehouse door had gaps of almost an inch which could allow entry of insects, rodents and other vermin to warehouse area. Ceilings of the warehouse were covered by an unidentified black substance in over 25% of the ceiling surface.
It was also observed that hose connections to points of use in the manufacturing area were not maintained and were found to contain stagnant (water), creating microbiological contamination risks.
GMP and regulatory compliance are fundamental for Pharma products including OTC products not only for stringent regulated markets and agencies, but for all markets to ensure quality, integrity and safety of products.
FDA has placed Dabur facility under Import Alert (66-40), meaning DWPE “Detention Without Physical Examination of Drugs From Firms Which Have Not Met Drug GMPs”. This effectively prohibits import of Drug products from the Dabur, Dadra Nagar Haveli facility into the US.
Remediations for serious cGMP violations could be long and arduous. Corrective and preventive actions will need to address:
The FDA 483 underscores the critical importance of diligent Quality and Management oversight — ensuring that the Quality Unit is empowered with adequate resources, authority, and responsibility to enforce cGMP and regulatory compliance across all pharmaceutical manufacturing operations, supported by regular management reviews and effective interventions.
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