European Inspection uncovers serious Deficiencies at Indian Sterile Manufacturer

In March 2026, the Croatian medicines agency HALMED inspected two manufacturing sites of an Indian sterile products manufacturer on behalf of the EU and identified serious GMP deficiencies, which are now available in the EudraGMDP database.

The inspection covered two manufacturing units at the Bavla site in Ahmedabad. Unit 1 manufactures general liquid and powder injectables, while Unit 2 produces beta-lactam antibiotics such as penicillins and cephalosporins, also as powders for injection.

Seven critical and nine major deficiencies in Production Unit 1

The inspection of Unit 1 identified seven critical and nine major deficiencies. The critical deficiencies primarily relate to a pharmaceutical quality system that does not function adequately: in the view of the authority, it does not cover the specific requirements of sterile manufacturing, including due to inadequate deviation management and an ineffectively implemented risk management system. In addition, airflow visualisations (smoke studies) do not correspond to the actual activities observed. Aseptic working practices, including training and behaviour, also do not comply with the requirements of Annex 1 of the EU GMP Guide. The authority further rated as critical the failure to provide requested documentation in a timely and transparent manner, combined with concerns about the authenticity of documents. Moreover, the inspection identified numerous deficiencies in the design and layout of premises and equipment (including the absence of suitable barrier systems). The lack of a validated procedure for container closure integrity testing (CCIT) of ampoules is also classified as critical. Other critical deficiencies relate to poor design of equipment for dispensing, sampling and mixing, inadequate material transfer routes and insufficient investigations of out-of-specification (OOS) results.

The major deficiencies relate, among other things, to sanitary/hygiene practices, premises and equipment, qualification and validation, aseptic process simulation (media fill), cleaning validation and cleaning practices, as well as computerised systems.

Three critical and twelve major deficiencies in Production Unit 2

The inspection of Unit 2 identified three critical and twelve major deficiencies. According to the authority, the manufacturer does not adequately minimise contamination risks arising from direct manual interventions in the critical zone (Grade A) during aseptic activities. Direct interventions are carried out under RLAF without a barrier system; in addition, aseptic technique and operator behaviour are not adequate. The authority also considers it critical that the sterility of disinfectants and cleanroom garments is not ensured in Grade A/B manufacturing areas. Another critical deficiency again concerns the quality system: the inspectors report that manufacturing deviations are not consistently reported, assessed, investigated and closed. Several deviations observed during the inspection remained unaddressed until inspectors drew staff attention to them.

Among the major deficiencies are, among others, cross-contamination risks in beta-lactam production (including in connection with material transfer into and out of clean areas and the design of production lines). The contamination control strategy (CCS), the media-fill programme (APS), the cleanliness and maintenance of manufacturing areas, inadequate gowning and poor hygiene practices of personnel, visual inspection and, again, container closure integrity testing (CCIT) are also criticised. Qualification and validation, as well as computerised systems, are likewise cited.

The authority announces the revocation of the GMP certificate. In addition, the suspension of marketing authorisations is being addressed. Recalls of already released batches are to be considered wherever a potential quality defect may impact public health. Finally, following the final non-compliance statement and for as long as it remains in force, a ban on imports from this site is to be considered.

The detailed non-compliance reports are available in the EudraGMDP database: Unit 1 under reference number 184409, Unit 2 under 184408.