B Ophthalmic for foreign particles Each batch of ointment is not appropriately tested to determine conformance specifications regarding the presence harsh abrasive substances. a Final report names of those involved The study did not include director other scientists professionals all supervisory personnel [...]

B Tamperevident feature to remain intact The is not designed does when handled reasonable manner during manufacture distribution retail display. a Oversight of production operations You did not oversee in manner to ensure that each PET drug meets the requirements FD Act as safety has identity and strength is supposed have quality purity characteristics CFR. a Criteria for establishing specifications You did not follow laboratory control processes use of appropriate [...]

Of an electronic product which was defective failed to comply with applicable Federal standard you produced assembled imported distributed. a Maintenance of grounds the is inadequate to protect against contamination food. a Recordsholding distribution originals copies electronic You did not keep the required for your and distributing operations as true . a No TID Each retort did not have at least one device that accurately indicated the temperature during processing. d Batch record year years You did not keep production records for the required time period [...]

F Management personnel understand their functions Testing facility failed to assure that all clearly understood they were perform. b Adequate lab facilities not available for testing and approval rejection of components drug product containers closures packaging materials inprocess products are to the quality control unit. a Adverse thorough investigation of each reported reaction was not made [...]

A iii Identity of treated animals Failure to assure that the foodproducing was maintained where you had prescribed or dispensed approved human drug contrary labeling. c Recordssigned dated Your written hazard analysis HACCP plan required by the juice regulation was were not and upon initial acceptance modification verification validation most responsible individual onsite CFR. a General Complaint handling procedures for receiving reviewing evaluating complaints have not been established defined documented completed implemented. b IRB registration information does not include the name mailing address street different from phone number facsimilie electronic [...]

PDF Guidance for IndustryU Food and Drug Administration. d Acceptance records The device history does not include complete that demonstrate manufactured accordance with master . b Approval inadequate purchasing data that clearly describe or reference specified requirements for purchased otherwise received product and services have not been approved established adequately . e limits You did not establish product specifications for contamination that may adulterate lead to adulteration of the finished dietary supplement [...]

B Reserve samples identified representative stored drug product are not appropriately of each lot batch retained and under conditions consistent with labeling. b Review not timely A processing production record was reviewed within working day after the actual before shipment release distribution to determine completeness of and ensure that received scheduled [...]

Contamination can be prevented protecting the health and safety of end users. d packaging You did not establish label specifications. a Recordsholding distribution originals copies electronic You did not keep the required for your and distributing operations as true . leh function r [...]

Primary packaging is vital element the pharmaceutical manufacturing process and one that directly affects drug being offered its shelflife efficacy. Specifically CFR . b Name and address on summary The of records for HCT Ps did not contain establishment that made determination. b Schedules and procedures for equipment calibration The standard operating fails to include written description of maintenance . Written records kept in individual logs of major equipment cleaning maintenance use are not included [...]

B Supplier notification of changes There is agreement with suppliers contractors consultants notify you in product service. a Timing before vent temperature reached of process began the retort was properly vented processing [...]

Language Assistance Available Espa ol Ti Vi Tagalog Русский Krey Ayisyen Fran ais Polski Portugu Italiano Deutsch English FDA Accessibility Careers Basics FOIA FEAR Act Site Map Website Policies . b Written procedures fail to include for cleaning and maintenance assignment of responsibility schedules description sufficient detail methods equipment materials used the CFR [...]

C i Multiple interlocks on doors A of cabinet xray system does not have at least two safety . d Batch recordcomponent unique identifier Your production records did not include the that assigned to received from supplier for packaging labeling dietary supplement used . b Precautions against contamination micro foreign substances Failure to take necessary protect of food contact surfaces packaging systems with microorganisms . g Identification Containers for samples fail to bear the donor before collection of [...]