Blog Stats
- 150,251 hits
www.friedmanconsultingllc.com
Blogroll
TUNGSTEN SHIELD WEBINARS
Warning Letters
-
Recent Posts
- A REVIEW OF AN EXTENSIVE ENDOTOXIN WARNING LETTER USING THE NEW FDA “ENDOTOXIN” Q&A AS A BACKDROP
- Mylan Laboratories, India Receives Warning Letter (08/06/2015)
- Quality Metrics and Risk Based Inspections
- FDA’s CDER LISTING OF TOP NINETEEN OBSERVATIONS FOR 2014
- 2015 United States Pharmacopeia (USP) Microbiological General and Information Chapters Training Program
Archives
- August 2015
- July 2015
- June 2015
- April 2015
- March 2015
- February 2015
- December 2014
- September 2014
- August 2014
- July 2014
- June 2014
- May 2014
- April 2014
- March 2014
- January 2014
- December 2013
- November 2013
- October 2013
- September 2013
- August 2013
- July 2013
- June 2013
- April 2013
- March 2013
- February 2013
- January 2013
- December 2012
- November 2012
- October 2012
- September 2012
- August 2012
- July 2012
- June 2012
- May 2012
- April 2012
- March 2012
- February 2012
- January 2012
- December 2011
- November 2011
- October 2011
- September 2011
- August 2011
- July 2011
- June 2011
- May 2011
- April 2011
- March 2011
- February 2011
- January 2011
Categories
- 483
- Adverse Determination Letter
- Compounding Pharmacy
- Consent Decree
- Dietary Supplements
- FDA Compliance
- Import Alert
- Import Ban
- Microbiological Issues
- New Guidances for Industry
- On-Site Training
- Permanent Injunction
- Positron Emission Tomography (PET)
- Purpose and Scope
- Recall
- Regulatory Compliance
- Seizure
- Uncategorized
- Warning Letters
- Webinar
Pages
-
Join 7 other subscribers
- 21 CFR 211
- 21 CFR 211.192
- 211.113(a)
- 211.113(b)
- 211.192
- Accugenix
- Annex 1
- API
- Aseptic Processing
- Bacillus
- Bacillus cereus
- bacteria
- bacterial contamination
- B cepacia
- Ben Venue
- Ben Venue Laboratories
- BVL
- CAPA
- CDER
- CMO
- Consent Decree
- contamination
- DNA Sequencing
- drug shortages
- endotoxin
- Environmental Monitoring
- FDA
- FDA 483
- FDA 483s
- FDA Compliance
- Form FDA 483
- GMP
- GMP Training
- Growth Promotion
- Guidance for Industry
- H&P Industries
- H & P Industries
- HEPA filters
- Hospira
- import alert
- injectables
- interventions
- Johnson & Johnson
- McNeil-PPC
- media fills
- microbial contamination
- Microbiological Contamination
- NECC
- non-sterility
- Objectionable microorganisms
- Observations
- OOS
- PDI
- Permanent Injunction
- Process Validation
- Puerto Rico
- purified water
- Ranbaxy
- Recall
- Risk Assessment
- seizure
- specifications
- Specified microorganisms
- sterile drug products
- Sterility
- Sterility Test
- Sterility Tests
- training
- Triad Group
- USP
- USP 61
- USP 62
- Validation
- Warning Letter
- Warning Letters
Meta
Tag Archives: aseptic filling
JUBILANT HOLLISTERSTIER RECEIVES WARNING LETTER (2/13/13)
ASEPTIC FILLING FACILITY RECEIVES SIGNIFICANT OBSERVATIONS Jubilant HollisterStier located in Kirkland, Quebec, Canada was audited by the FDA on March 19-26, 2012. Following the receipt of the Form FDA 483, the Company responded on April 13, 2012 to the Observations … Continue reading
PHARMACEUTICAL COMPANY JELFA SA (POLAND) RECEIVES WARNING LETTER (7/14/11) PART II
JELFA SA FAILS TO FOLLOW FDA’S ASEPTIC PROCESSING GUIDANCE FOR INDUSTRY (SEPTEMBER 2004) 2. Your firm has not established appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile [21 C.F.R. § 211.113(b)]. For example, a. During … Continue reading
Barry A Friedman, PhD LLC 