B Sanitation monitoring You are not the conditions and practices with sufficient frequency assure conformance Current Good Manufacturing including safety of water that comes into contact food surfaces CFR. b Written record not kept of program and validation data the along with appropriate has been maintained situations where backup is eliminated by computerization other automated processes. d Radioactive materials for parenteral usepreparation The RDRC did not determine that were prepared sterile pyrogenfree form [...]

B Backflow prevention Lack of protection from piping systems that discharge waste water sewage. b Batters breading gravies sauces etc [...]

Containersclose fitting covers Garbage lack closefitting . a ii Your process monitoring equipment is not calibrated ensure that reads accurately. a Timing before vent temperature reached of process began the retort was properly vented processing [...]

C Availability of procedures for core CTGP requirements were not available to personnel in the area where operations performed nearby when such is impractical. b Training records Personnel is not documented. e intended use You did not establish appropriate controls to ensure that your automated mechanical or electronic equipment functions accordance with its [...]

B Product rework documentation DHR see also. b Cleaning SOP inspection Procedures for the and maintenance of equipment are deficient regarding cleanliness immediately before use. e Review of problem drugs The procedures for annual quality standards record evaluation are deficient in that they do not address complaint recall returned product salvaged investigation records each . a Adequate facilities for cleaning bactericidal treatment are not provided the of multiuse eating and drinking utensils equipment used preparation food beverages [...]

B Document changes review and approval communication to documents were not reviewed approved by individual the same function or organization that performed original communicated appropriate personnel timely manner. a Lack of or inadequate process validation whose results cannot be fully verified by subsequent inspection and test has been adequately validated according to established procedures [...]

A Calibration Inspection etc. Availability Required records are not maintained at location that is reasonably accessible to responsible officials the manufacturer and employees FDA were made readily available for review copying by legible store CFR. g Critical factors record minutes specified the scheduled process was not measured recorded at intervals of less. b Employees keeping birds at home are allowed to [...]

A Bleeder size was not inch millimeters or larger. b Reason for Not Conducting Complaint Investigation records are deficient that they do document and individual making decision to . b Document change records maintained [...]

A Minutes of IRB meetings have not been prepared maintained sufficient detail to show attendance the actions taken by vote including number members voting for against and abstaining basis req CFR. b Other sponsor records required by FDA inadequate that requires to be maintained for category of investigation particular are not all accurate complete current [...]

A More frequent reviews verification of no changes The IRB has did not follow its written procedure for determining which projects require often than annually need from sources other investigator that material have occurred since previous CFR. g Design validation acceptance criteria were not established prior to the performance of activities. a Confidentiality FDA inspection of records There was no statement informed consent document that described extent if any to which identifying subject would maintained noted possibility Food and Drug Administration might CFR. c Design input requirements were not adequately documented [...]

A Holdreserve sample closure system Your of dietary supplement was not held using the same which packaged and labeled distributed. e Signs Lack of posted readily understandable directing employees to wash sanitize hands appropriate. Finished product not analyzed for li You do always your juice biotype Escherichia coli [...]

D Plumbing design installation maintenance is not designed installed maintained so as to prevent contamination of the water supply food utensils. a Approve or reject components products The quality control unit lacks responsibility and authority to all drug containers closures process materials packaging labeling . b Preventive control measures Failure to use adequate sterilization irradiation pasteurization freezing refrigeration pH water activity destroy or the growth of undesirable microorganisms food [...]