The Elsmar Cove Forum > National and International Business Standards > FDA (United States Food and Drug Administration)

1. Any difference in FDA inspections since the risk-based approach was announced?
2. Nickel Allergies - How low of a percentage of nickel can be in stainless steel?
3. FDA - Change of US Agent - Don't want to use the US agent for our own products
4. Retroactive application of harmonized standards
5. Are there any guidelines for writing an Intended Use statement?
6. FDA - Audit - Response - Observation form 483. Do we now receive a formal letter?
7. Anyone have experience with ISO/IEC 15189 for medical laboratories?
8. FDA is nobody's "lapdog"
9. Does anyone have any information on FDA's SMG 2020 issued Oct 04.
10. Is anyone out there considering using a Third-Party for their FDA Audit?
11. FYI - FDANews Calls for authors
12. Is a registrar obligated to inform the FDA of NCRs that could be considered 483s?
13. How does the FDA's SMG 2020 compare to ISO/TR 10013:2001?
14. FDA District Office - How do you know which one to contact?
15. Can pharmaceutical companies delegate some responsibilities to supplier?
16. Top FDA guy resigns - impact on industry?
17. Instructions for Use (IFU) - On the manufacturer's website vs. On the product label
18. Where to find FDA requirements for new products
19. For non-US manufacturors: Statement of distributor on insert/labelling
20. How costly can a quality system problem be? Guidant vs. the FDA
21. Good Manufacturing Practices - How you document your GMP's - GHP's and how detailed
22. Implementation of the FDA requirements into the existing Quality Management System
23. Correction Fluid on documents - FDA regulations?
24. FDA Requirements for Document Approval by Quality Department
25. cGMP and Batch Integrity of Bulk Storage Tanks
26. FDA Epoxy Floor Paint Specifications
27. Effective system to track a Technology Transfer to a sister plant
28. List of Approved Test Laboratories by FDA
29. Best practices for GMP training
30. What should generate a CAPA (corrective action - preventive action)
31. Blinding Checks for labels in a clinical study
32. FDA holding toothpaste imported from China at Customs for testing?
33. The differences between FDA and ISO 9001 Audits
34. Dried Food Packaging - Getting FDA registered / approved
35. Audit checklist for Cosmetics
36. FDA Audit next week
37. FDA warns on Hot Dog Chilli Sauce
38. FDA warning on canned French Cut Green Beans
39. Approval - FDA and ISO Definitions
40. FDA Expands Warning on Eating Raw Oysters
41. Customer is FDA Certified - Must we also be FDA Certified?
42. Is there such a thing as FDA Good Documentation Practice (GDP)?
43. Approximately $2 Million of Potentially Harmful "Cosmetic" Eye Product Seized
44. Status of Material Safety Data Sheet (OSHA Compliant) vs. 10993 Certificate
45. Statistical Analysis during Document Audit
46. FDA Launches Email Alert Subscription Service
47. Obtaining Documents from the FDA in Frame of FOIA
48. Where to draw the line with Red Lining?
49. How often does the FDA inspect organisations outside of the USA?
50. GTP (Good Tissue Practice) & GLP (Good Laboratory Practice) Certification
51. Customer Changes to Customer Supplied Documents - Testing Instructions
52. Good Documentation Practice (GDP) - Actual Results (can they be typed)?
53. FDA Requirements and/or Standard for Infant Formula Glucose Content
54. Production and Process Control SOP example or template needed
55. FDA Proposes Guidance for Dissemination of Info on Unapproved Uses of Med Products
56. FWIW: FDA confused?
57. Using Faxed Hand Signatures for Approval Records
58. Non-Dairy Creamer - Is there an FDA or other standard for Non-Dairy Creamers?
59. FDA on path to establish offices in China
60. question on FDA and Health Canada
61. The new FDA internet home page - March 2008
62. Is there an FDA guidance on how to distinguish between Complaint and Repair?
63. Effects of substrate on biological indicator organisms
64. Has anyone had to do labeling/comprehension testing?
65. "Performance Specification" vs. "Specification"?
66. Reference to FDA on label or labelling
67. List of Countries that require 'Certificates to Foreign Governments' (CFG)
68. FDA Embarks on Major Hiring Initiative for its Public Health Mission
69. Email Exposure - Inappropriate statements uncovered in emails
70. Laboratory of Assay for Poliolefinas - Section 177.1520 of the FDA and AP89
71. SOP - Notification to Management of critical or major quality issues
72. Do we need FDA Approval of the Manufacturing Facility and how do you go about it?
73. Who is it manufactured by? Manufactured by vs. Manufactured for
74. FDA Warns Consumers Nationwide Not to Eat Certain Types of Raw Red Tomatoes
75. Procedure on Traceability - FDA audit finding
76. When the FDA comes a knockin
77. California FDB (Food & Drug Branch) inspection experiences?
78. Temperature and humidity storage requirements?
79. Sterile Field - Legal/formal definition
80. Relationship between "Corrections/Removals" procedure and "Recall" procedure
81. Industry Standard for Correcting Dates on Documents
82. PMAP (single outside audits for both FDA, HC)--anyone doing?
83. Investigator - Lead Study - FDA pitfalls?
84. A question arising in my lab in a GLP (Good Laboratory Practice) study
85. 3rd Party Facility Inspections - In a manufacturer's best interest?
86. List of FDA approved Manufacturing facilities (India) ??
87. When to issue a CAPA (corrective action preventive action)?
88. FDA opens new China office in Beijing yesterday
89. Millions unknowingly taking unapproved meds
90. Who does QC (Quality Control) report to?
91. Obama’s health team needs your input
92. Requirement to save original, handwritten internal audit notes?
93. FDA opens offices in India (New Delhi and Mumbai)
94. Health Hazard Evaluation (HHE) template needed
95. NFPA 99:2005 will have a new edition in 2010 - What will the changes be?
96. One website/marketing material for two companies
97. New FDA Chief Viewpoints - February 2009
98. Certificate for Foreign Government - How long it takes for an approval?
99. GLP (Good Laboratory Practices) Requirements and Audit
100. Gearing up GMP based systems for continual improvement.
101. President Obama Picks Dr. Margaret Hamburg as FDA Chief
102. List of FDA Required Procedures
103. Make GMP product in non-GMP facility?
104. New workshop at different address - Do I have to update the establishment info?
105. Response to FDA 483. Responded within 14 days and now waiting for reply
106. A specification developer or not? Contract design and development for a subsystem
107. Is there anyone who can help me check my instruction booklet
108. Standard on Clean room - Where can I buy ISO 14644-1 and ISO 14644-4
109. Handling, Storage and Distribution-Package validation Test Method Options?
110. US FDA plans to launch new website
111. Minimum Gowning Requirements for ISO Class 8
112. Why does it take so long for a Food Recall to come out?
113. Fine Lines and Preorbital Wrinkles - FDA not regulating skin rejuvenation
114. Original written signatures vs. Copies/scans/faxes/electronic documents
115. Customer Complaint - FDA Definition of Complaint
116. FDA guidelines for Calibration Lab needed
117. Filter cleaning procedure for Clean Room Air Handling Unit example wanted
118. Silly customers - Customer On-Site Audits
119. What do we need to do to be certified as a GLP laboratory?
120. Why "c" is small for cGMP (current Good manufacturing Practices)
121. New sub-forums within the FDA forum
122. Does FDA change the information about" wire transfer"
123. FDA delaying notification of receipt of 510(k)'s - What wrong with FDA? - China
124. Anyone having procedure on "Handling Regulatory Audits" ?
125. FDA Issues concerns on "e-cigarettes"
126. 510k third party review of class II medical device
127. ASR (Analyte Specific Reagents) Primers? Clinical Genetic Testing laboratory
128. Classification for antiseptic and disinfection solutions
129. Draft FDA Guidance on "Presenting Risk Information in Prescription Drug and Device"
130. About FY 2010 MDUFMA foreign small business qualification certification
131. Require an audit checklist for auditing Cosmetics manufacturers
132. Total Organic Carbon (TOC) testing - USP requirements
133. Questions: Plastic Food Container to comply with FDA
134. Draft Guidance: eMDR - Electronic Medical Device Reporting (Updated)
135. Am I subject to FDA regulations in Europe? Sales/service branch of an organization
136. COAs for 21 CFR 111 - Identity, Purity, Strength - Dietary Supplement Industry
137. US FDA Proposed Rule for Combination Product Reporting
138. CFG - Certificate for Foreign Government - Medical Device Company based in CA, USA
139. ISO 13485 and ISO 14971 - Medical Devices and Related Forums
140. FDA Approved Ultrasonic Equipment - FCC Requirements for US sales
141. FDA Application for a Class IIa CE Marked Product bought from another company
142. FDA Inspector - What does it take to become an FDA inspector?