Three Mumbai blood banks, including the public-private partnership unit at Cooper Hospital, have been suspended by the Food and Drug Administration (FDA) over safety and compliance violations involving blood storage, documentation, disinfection and supply authorisations. The suspensions follow inspections conducted in August and will remain in force for periods extending to November 7, according to documents reviewed by the Times of India.
The Cooper Hospital blood bank, operated by Samarprit Bahuddeshiya Sevabhavi Vikas Sanstha, was initially suspended for five days. Its suspension period was reduced by three days after an appeal, with services suspended on Thursday and Friday and permission to resume on Sunday. Hospital authorities said they would rely on the blood bank at Trauma Hospital in Jogeshwari for the intervening three days.
FDA officials said the suspension notice had been served 90 days earlier. At the Cooper facility, the violations were described largely as documentation-related. Multiple forms were incomplete because donors’ full residential and communication addresses had not been recorded, according to the inspection findings.
More serious violations were recorded at two private blood banks in Ghatkopar East: Deepak Foundation’s Anviksha Blood Centre and Samarpan Blood Centre. Both facilities were suspended for 11 days, from October 28 to November 3. The centres are located close to BMC-run Rajawadi Hospital.
At Samarpan Blood Centre, blood was supplied to Surya Hospital’s blood storage centre without an agreement or approval from the licensing authority. The inspection also found partly thawed fresh frozen plasma units in deep freezers. Only one or two platelet bags out of 500 to 600 handled each month were being tested for sterility, against the required level of 1%, the document said.
The findings at Samarpan also included gaps in the consent form used for single-donor plateletpheresis. The form did not explain the risks of the procedure, in which blood is drawn, separated and returned to the donor. Donors were also not screened for anticoagulant or antiplatelet medication other than aspirin, according to the inspection record.
At Anviksha Blood Centre, opened blood-bag foil packs were not resealed and their opening dates were not marked. Sterility testing of empty blood bags used a five-day incubation period instead of the required 14 days. The facility also failed to disinfect positive blood bags with hypochlorite, the document noted.
Hospital officials said patients may have obtained blood from the two Ghatkopar centres if Rajawadi Hospital’s own blood bank faced a shortage. They clarified, however, that no adverse event had been recorded so far. The suspensions and the stated resumption arrangements were based on the FDA’s inspection findings and subsequent action.
