Guide to Inspections of:

• Biotechnology
• Biologics
• Computer Issues
• Devices
• Drugs
• Foods Cosmetics
• Miscellaneous

Note: These documents are reference material for investigators and other FDA personnel. The documents do not bind FDA and do not confer any rights, privileges, benefits or immunities for or on any person(s). An alternative approach may be used if such an approach satisfies the applicable statutes, regulations or both.

Updated: April 2001

Guides to Inspections of:

BIOTECHNOLOGY

• BIOTECHNOLOGY INSPECTION GUIDE(11/91)

BIOLOGICS

• BLOOD BANKS(9/94)
• SOURCE PLASMA ESTABLISHMENTS (Rev 4/01)
• INFECTIOUS DISEASE MARKER TESTING FACILITIES(6/96)
• VIRAL CLEARANCE PROCESSES FOR PLASMA DERIVATIVES

COMPUTER ISSUES

• COMPUTERIZED SYSTEMS IN DRUG ESTABLISHMENTS(2/83)
• COMPUTERIZED SYSTEM IN THE FOOD PROCESSING INDUSTRY
• GLOSSARY COMP. SYSTEMS. SOFTWARE DEVELOPMENT TERMINOLOGY(8/95)

DEVICES

• QUALITY SYSTEMS
• ELECTROMAGNECTIC COMPATIBILITY ASPECTS OF MEDICAL DEVICE QUALITY SYSTEMS
• BIORESEARCH MONITORING INSPECTIONS OF IN VITRO DIAGNOSTIC DEVICES
• MAMMOGRAPHY QUALITY STANDARDS ACT AUDITOR'S GUIDE
• MEDICAL DEVICE MANUFACTURERS

DRUGS

• BULK PHARMACEUTICAL CHEMICALS(9/91)
• HIGH PURITY WATER SYSTEMS(7/93)
• LYOPHILIZATION OF PARENTERALS(7/93)
• MICROBIOLOGICAL. PHARMACEUTICAL QUALITY CONTROL LABS(7/93)
• PHARMACEUTICAL QUALITY CONTROL LABORATORIES(7/93)
• VALIDATION OF CLEANING PROCESSES(7/93)
• DOSAGE FORM DRUG MANUFACTURERS - CGMP'S(10/93)
• ORAL SOLID DOSAGE FORMS PRE/POST APPR. ISSUES(1/94)
• STERILE DRUG SUBSTANCE MANUFACTURERS(7/94)
• TOPICAL DRUG PRODUCTS(7/94)
• ORAL SOLUTIONS AND SUSPENSIONS(8/94)

FOODS COSMETICS

• ALLERGY INSPECTION GUIDE(April, 2001)
• NUTRITIONAL LABELING AND EDUCATION ACT (NLEA) REQUIREMENTS (8/94-2/95)
• COSMETIC PRODUCT MANUFACTURERS(2/95)
• COMPUTERIZED SYSTEMS IN THE FOOD PROCESSING INDUSTRY
• GRAIN PRODUCT MANUFACTURERS
• INTERSTATE CARRIERS AND SUPPORT FACILITIES(4/95)
• DAIRY PRODUCT MANUFACTURERS(4/95)
• MISCELLANEOUS FOOD PRODUCTS-VOL. 1(5/95)
• MISCELLANEOUS FOOD PRODUCTS-VOL. 2(9/96)
• LOW ACID CANNED FOOD MANUFACTURERS Part 1 - ADMINISTRATIVE PROCEDURES/SCHEDULED PROCESSES
• LOW ACID CANNED FOOD MANUFACTURERS Part 2 - PROCESSES/PROCEDURES
• ACIDIFIED FOOD MANUFACTURERS
• TRACEBACK OF FRESH FRUITS AND VEGETABLES IMPLICATED IN EPIDEMIOLOGICAL INVESTIGATIONS

MISCELLANEOUS

• FOREIGN MEDICAL DEVICE MANUFACTURERS(9/95)
• FOREIGN PHARMACEUTICAL MANUFACTURERS(5/96)