• Login
Redica Systems
  • For Pharma

    Our data generates critical pharma insights with our actionable data intelligence helping your team go from reactive to proactive.

    For MedTech

    Elevate your MedTech quality and regulatory strategies with our comprehensive intelligence solutions and unparalleled dataset.

  • Catalyst
  • About Us
    • People
    • Careers
    • Press
  • Resources

    View all Resources

    • Assessments
    • Reports
    • Webinars
    • Glossary
  • Blog
Request a Demo
Redica Systems
    • Redica Systems MedTech Intelligence
    • Redica Systems Pharma Intelligence
  • Catalyst
    • About Redica Systems
    • People
    • Careers
    • Press
  • Resources
  • Blog
Request a Demo
  • Login

Resources

RAPS | April 26, 2019

Scope of FDA Draft Guidance on Nonbinding Feedback is Too Restrictive, Industry Argues Read the full article here. Original Source: https://www.raps.org/news-and-articles/news-articles/2019/4/scope-of-fda-draft-guidance-on-nonbinding-feedback

Researching Combination Product Enforcement

When it comes to scanning 483 observations, can a 15-second search replace hours (or weeks) of research and still provide enough data? Yes, and more. Using AI technology and human expertise, the process of researching enforcement and observation trends has become efficient and effective. The Old Way of Researching Combination Products Before the introduction of […]

Week of April 14th, 2019 | FDA Sent These Warning Letters to Pharma/Device Companies

This week FDA posted 11 warning letters to dietary supplement manufacturers, one issued regarding tobacco, two to pharma firms, and one to a compounding pharmacy. We cover the last three here. DRUGS | Luen Fook Medicine Sdn. Bhd. Luen Fook Medicine Sdn. Bhd. (Singapore) received a warning letter on April 4, 2019 based on the outcome […]

Govzilla and FOI Services Announce Strategic Partnership

Govzilla and FOI Services announced Tuesday, April 16th, 2019 the beginning of their official partnership that integrates FOI Services’ unique and vast dataset with Govzilla’s innovative analytics tools to help solve regulatory intelligence problems. FDA regulated industries’ need for immediate access to enforcement documents is growing as more companies expand their markets and supply chains […]

Week of April 7th, 2019 | FDA Sent These Warning Letters to Pharma/Device Companies

Enforcement was slow this week. No drug or medical device GMP warning letters were issued except for two to compounding pharmacies, a rarity. We cover those two here. The FDA still has not published the warning letter issued to Lupin Pharmaceuticals that the firm disclosed a few weeks ago. COMPOUNDING PHARMACY | Apollo Care LLC Apollo Care LLC […]

Week of March 31st, 2019 | FDA Sent These Warning Letters to Pharma/Device Companies

Enforcement in terms of warning letter posting was busy this week. Among those issued were four that were sent to homeopathic drug product manufacturers, continuing a focus evident over the past two years (you can find the FDA press release here). Lachman Consultants released their perspective last week. In addition, there were another two to drug product […]

Week of March 25, 2019 | FDA Sent These Warning Letters to Pharma/Device Companies

FDA posted 9 warning letters this week. This included two to pharmaceutical firms and two to compounding facilities. We cover these four below. The FDA has not yet published the warning letter issued to Lupin Pharmaceuticals that the firm disclosed a couple weeks ago. DRUGS | Mariposa Labs LLC Mariposa Labs LLC (Boise, ID) received a warning […]

CDER Warning Letter Trends by Facility Type

Recently, the CDER warning letter issuance skyrocketed from 70 in FY2014 to 128 in FY2018, an increase of 83%. What types of firms are taking the heat? And where are they located? Here we answer these questions and more with a review of CDER warning letter trends in regard to facility type, including: Year-over-year analysis […]

Week of March 18th, 2019 | FDA Sent These Warning Letters to Pharma/Device Companies

We cover four warning letters this week including one for a human drug and three to device manufacturers, two of which are manufacturers of breast implants that failed to conduct post-approval studies. DEVICE | TEI Biosciences Inc. TEI Biosciences Inc. (Plainsboro, NJ) received a warning letter on March 6, 2019 based on the outcome of […]

Week of March 10th, 2019 | FDA Sent These Warning Letters to Pharma/Device Companies

Warning letters posted this week include ones demonstrating FDA’s continued focus on over-the-counter (OTC) product manufacturers and manufacturers in India, including a particularly testy letter to Pfizer for a Hospira site in India that they are closing. Lupin announced that they received a warning letter, but it has not been posted by the FDA yet. […]
« Older Entries
Newer Entries »
Company
  • About Redica Systems
  • People
  • Careers
  • Press
  • Contact Us
Catalyst
  • Redica Catalyst
  • Redica ID
  • Enrichment
  • Knowledge Graph
  • Redica Ontologies
Use Cases
  • For Pharma
  • For MedTech
  • Inspection Preparation
  • Vendor Quality
  • Regulatory Surveillance
Resources
  • Assessments
  • Reports
  • Webinars
  • Document Store
  • Blog
  • Glossary

© 2025 Redica. All Rights Reserved.

  • Privacy Policy
  • Terms of Use
  • Status