What Do FDA Investigators Look For At Compounding Facilities?
Recent FDA-483’s and Warning Letters reveal patterns of common observations by the FDA at compounding facilities. Did you know that you can find this information on fda.gov and get a head start in preparing for when the Agency knocks at your door?
The FDA’s Insanitary Guidelines for Compounding Facilities remains a strong reference for compounders to utilize in determining the compliance of their operation. However, many compounders experience challenges in interpreting and implementing these requirements as revealed by the warning letters issued between 2019 and 2020 which show observations related to Insanitary Conditions.
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Below Are Some Common Observations in 2020
- Failure to Meet the Conditions of Section 503A
- Drug products intended or expected to be sterile were prepared, packed, or held under insanitary conditions
- Smoke Studies not performed under dynamic conditions
- Media fills not performed under stressful conditions
- Failure to establish and follow appropriate written procedures
- Use of non-pharmaceutical grade water as a component of non-sterile drug products, and non-pharmaceutical grade alcohol as a component of sterile drug products.
- Inadequate cleaning procedures
- Failure to establish an adequate system for monitoring environmental conditions
During our 2020 Pharmacy Compounding Virtual Seminar, our panelists will dive deep into revealing the common findings that have resulted in costly operational interruptions at compounding facilities. Learn to avoid these common mistakes and stay ahead of regulatory scrutiny at the Eagle Virtual Seminar on Wednesday, November 3, 2020.
Who We Are
Eagle consultants and scientists are helping compounding facilities implement successful quality systems. Our team has over 200 years of combined experience in the FDA-regulated pharmaceutical industry and can provide guidance in establishing the systems and processes that will help facilities producing compounded medications meet and exceed regulatory expectations. Follow the link below to learn more about our consulting services.
- Antimicrobial Effectiveness | USP 795 & 797 Revisions - July 18, 2023
- 2023 PDA/FDA Joint Regulatory Conference, 09/18 – 09/20 - July 11, 2023
- APC: Compounders on Capitol Hill, 09/19 – 09/20 - July 11, 2023