(Bloomberg) -- A Pfizer Inc. plant in China that wasbeing inspected by Food and Drug Administrationregulators in order to ship drugs to the U.S. kept a second set ofquality and manufacturing records that didn’t match official ones,according to an FDA review of the facility.

During an April inspection of Pfizer’s plant in the northernChinese city of Dalian, FDA inspectors said in their report thatemployees hid quality failures, used expired manufacturingmaterials or ones that hadn’t been recently checked, and retestedfailing products until they passed.

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Details of the inspection were described in an FDA report calleda Form 483 that was obtained by Bloomberg News. Mackay Jimeson, aPfizer spokesman, confirmed Pfizer’s ownership of the plant.

“Pfizer has responded and addressed the issues raised during apre-approval inspection of our manufacturing site at Dalian,”Jimeson said in an e-mailed statement. “The issues cited in the FDAForm 483 do not indicate any quality or safety concerns and do nothave any impact on products currently on the market manufactured atthe Dalian site. Patient safety is of utmost importance to Pfizer,and Pfizer is committed to ensuring the safety and quality of ourmedicines.”

Jimeson declined to say what products the plant manufactures.The FDA declined to comment about the report. The FDA typicallyconducts an inspection of a manufacturing facility before it’sallowed to ship to the U.S.

Moved documents

Workers at the plant also moved manufacturing records asthe FDA inspectors were going through the facility, according tothe FDA report.

In one room, FDA officials said they found an 8- inch high stackof documents.

When they returned 10 minutes later, the documents were gone.When they asked for the documents, a factory official only broughtabout a third of the papers back.

“We then requested an interview with the individual responsiblefor the removal of the documents, and found that he had removed theremaining 2/3 stack from the manufacturing area and placed them inthe upper-floor construction/expansion area within a wooden crate,”FDA inspectors said in the report.

Manufacturing records

The missing documents were a set of manufacturing records.

Their content, including manufacturing batch numbers of drugmaterials, temperature and humidity conditions, and manufacturingyield, did not match the plant’s official manufacturing recordsthat were also inspected by the FDA, according to the agency’sreport.

On two pages from the set of records that had gone missing,inspectors said they also found sticky notes stating that drugmanufacturing materials were expired or past the date where theyneeded to be retested.

The problems the FDA said it found at the plant resemble similarissues at Chinese drug ingredient suppliers for Westernpharmaceutical companies, according to FDA inspection documents,previous Bloomberg reports, and a previous interview with the FDA’stop official in China.

Other plants

In inspections of other drug plants, the FDA found issues withdata integrity at manufacturing facilities owned by Zhejiang HisunPharmaceutical Co. and Zhejiang Hisoar Pharmaceutical Co. earlierthis year.

Both make main ingredients for drugs sold in the U.S. Neithercompany is owned by Pfizer, though Hisoar has a 20-year agreementto supply antibiotic products to Pfizer Asia Manufacturing PteLtd., a subsidiary of the New York-based drugmaker, according to a2012 stock exchange filing.

Pfizer has said that it’s aware of the past problems at Hisoar,and had taken action to ensure that the quality of its finishedproducts wasn’t impacted.

Hisun has said it’s working to fix problems at the plant. Thecompany has said it retested the samples in question and they metstandards. Hisoar declined to comment when asked by Bloomberg thismonth about its FDA inspection.

At Pfizer’s Dalian plant, the agency observed that when tests ofdrug products failed to meet standards, the same products werere-tested until passing results were achieved, and that theoriginal failures were never reported or investigated.

The FDA inspectors also noticed that one manufacturing unit hadonly one stand-alone toilet in significant disrepair 50 yards fromthe aseptic manufacturing unit.

Inside the facility inspectors saw no hand washing station andan open pit appeared to be used as a urinal.

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