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





