References to the Word "Temperature" in the FDA's Internal Inspection Training Guides

The following table shows references to the word "temperature" in the inspection guides that are used by the FDA to train auditors. A search of the word "temperature" in the FDA warning letter database returns more than 1600 items.

 

FDA Inspection Guide

#  Temperature References

   

BIOTECHNOLOGY

 
Biotechnology Inspection Guide

13

Blood Banks

24

Infectious Disease Marker Testing Facilities

10

Viral Clearance Process for Plasma Derivatives

4

   

DRUGS

 
Bulk Pharmaceutical Chemicals

6

High Purity Water Systems

2

Lyophilization of Parenterals

39

Microbiological. Pharmaceutical QC Labs

2

Dosage Form Drug Manufacturers - CGMP'S

9

Oral Solid Dosage Forms Pre/post Appr. Issues

3

Sterile Drug Substance Manufacturers

6

Topical Drug Products

15

Oral Solutions and Suspensions

7

   

FOOD

 
Aseptic Processing and Packaging

52

Computerized Systems Food Processing Industry

45

Guide to Produce Farm Investigations

6

Interstate Carriers and Support Facilities

23

Dairy Product Manufacturers

50

Miscellaneous Food Products-Vol. 1

17

Miscellaneous Food Products-Vol. 2

9

   

 

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