OAI Classification for Sun Pharma Halol Facility

In September 2025, the USFDA classified Sun Pharmaceutical Industries Ltd.’s Halol facility as OAI (Official Action Indicated) following a inspection conducted from June 2–13, 2025. The inspection conducted by USFDA investigators—Justin A Boyd, Pratik S. Upadhyay, and Lisa L. Flores—identified multiple critical deviations from current Good Manufacturing Practices (cGMP), including repeat observations from prior regulatory actions.

The key deficiencies included lapses in aseptic area practices and inadequate validation of aseptic processes, failure of investigations to identify root causes and CAPAs, equipment design and timely maintenance, inadequate process controls procedures, lapses in laboratory controls and documentation and retention of original data from visual inspection.

1. Lapses in Aseptic Practices and Operator Technique

• Several lapses were observed in operator practices and aseptic techniques in Grade A area filling line which included:

• • Transfer of tools and tanks into Grade A areas without proper disinfection.
  • Gloved hands held over open vials and sterile stopper bowls during interventions.
  • Fallen vials handled directly with gloved hands.
  • Operator gown touching with Grade A surfaces due to space / design constraints.
  • Inadequate space for environmental sampling near aseptic connections
  • Poor aseptic area gowning practices of operators
  • Execution time discrepancies: It was also observed that during inspection the time taken between removal of wraps on installed equipment to the start of filling was more than 3 hours while on prior batches it was completed in around 51 minutes. Similarly, during inspection sampling for environmental monitoring sampling took 42 minutes while on prior batches it was 15-17 minutes. There was no explanation how these same processes which require slow and controlled observed movements could be completed in less time on other occasions compared to that during inspection.

2. Inadequate Aseptic Process Simulation (Media Fills) Studes

• Aseptic process simulation  / media fill studies fail to represent actual manufacturing process

• • Non removal vial samples for in process fill volume verification during media fill

• • Operators reached over open outlets of filling tank during commercial batches
  • Air monitoring devices were not positioned near aseptic connections during commercial batches
  • Smoke studies involved only one operator during aseptic connections, unlike actual batch operations.
  • Qualification process for aseptic personnel did not specify or document all required activities to be performed during media fill

3. Lapses in Failure Investigations: OOT/OOS and Environmental Excursions

• • Investigations into environmental and personal monitoring excursions frequently failed to identify root causes, potential sources for identified organisms and implement appropriate CAPAs
  • OOT results during stability studies were not investigated promptly. This further led to failure of batches within expiry and delayed closure of these OOS led to expired batches remaining in distribution.
  • Procedure for OOT investigations were lacking as it allowed decision for laboratory investigation to the discretion and discussion between QC and QA. Also such discussions were not documented.

4. Equipment Design and Maintenance Failures

• Recurring metal particulate contamination traced to damaged filling machine parts. Risk assessments identified design flaws, but corrective actions were not extended to all similar equipment.

5. Deficiencies in Production and Process Control Procedures

• Visual inspection SOPs lacked guidance for detecting a new defect of black particles that settle over time and to and to avoid jerking and shaking of the vials until they are inspected.
• Challenge kits for training and qualifying Visual Inspectors did not include representative defect samples and inspectors were not trained and qualified for identifying these new defects.
• In tablet compression, reject percentages for compression force were not supported by the individual tablet weight data and do not consider other parameters, like hardness.

6. Laboratory Controls and Analytical Method Transfers

• Method transfers were inadequate and resembled analyst qualification and retest analysis. It only involved analysis of the same sample at the Receiving Unit (RU) by Transfer Unit (TU) analyst and RU analyst using same reagent, equipment, column, and reference standard.
• No variable involved in analysis to ensure transfer of method is accurate and reliable.

7. Timely Maintenance of Equipment

• Stability chamber (2-8⁰C) showed:
  • Cracks on the ceiling with microbial growth (bacterial, fungal, mold in dark black to brown and reddish, off white colour colonies).
  • Liquid was seen dripping from ceiling onto stored samples.

8. Batch Documentation Not complete, Original

• • Labels used to record initial visual inspection results were discarded after the results were transcribed into the batch record.
  • There is no documented second-person verification process to ensure the accurate transfer of inspection results from the labels to the batch record.

The inspection findings underscore the importance of rigorous training and qualification of operators in aseptic techniques and behaviour, adequately designed facilities and equipment, proactive maintenance and correction / replacement of defective equipment, timely investigation and remediation actions of OOT / OOS incidents, adequate process control procedures and GMP documentation complying with ALCOA+ principles. Above all there should be sustained Quality and Management oversight and control over the drug manufacturing operations to ensure continued cGMP compliance and product safety and integrity.

References:

• Sun Pharma Press Release on OAS Classification of Halol Facility (September 2025)
• Sun Pharma Halol Facility USFDA 483 (June 2025)