Professional Compounding Centers of America dba PCCA — FDA Warning Letter Findings

All drugs from (b)(4) , FEI (b)(4) , were listed on IA 66-40 on (b)(4) , and the firm was issued a warning letter on (b)(4) , for among other things, (b)(4) . All drugs from (b)(4) remain listed on IA 66-40 at this time.

All drugs from (b)(4) , FEI (b)(4) , were listed on IA 99-32 on (b)(4) , due to the firm’s denying FDA’s attempt to schedule a pre-announced inspection. All drugs from (b)(4) remain listed on IA 99-32 at this time.

All drugs from (b)(4) , FEI: (b)(4) , were listed on IA 99-32 on (b)(4) , due to the firm’s refusing to accept proposed inspection dates. All drugs from (b)(4) remain listed on IA 99-32 at this time.

All drugs from (b)(4) , FEI (b)(4) , were listed on IA 66-40 on (b)(4) , and the firm was issued a warning letter on (b)(4) , for among other things, inadequate impurity testing, and lack of audit trails to support CGMP activities. FDA determined that the firm had adequately addressed the deviations on (b)(4) . A WLCO letter was issued on (b)(4) and the firm’s drug products were removed from IA 66-40 on (b)(4) .

All drugs from (b)(4) , FEI (b)(4) , were listed on IA 99-32 on (b)(4) , due to the firm’s delaying and ultimately denying an inspection. All drugs from (b)(4) remain listed on IA 99-32 at this time.

All drugs from (b)(4) , FEI (b)(4) , were listed on IA 66-40 on (b)(4) , and the firm was issued a warning letter on (b)(4) , for among other things, a failure to ensure that quality-related complaints are investigated and resolved. All drugs from (b)(4) remain listed on IA 66-40 at this time.

All drugs from (b)(4) , FEI (b)(4) , were listed on IA 66-40 on (b)(4) , and the firm was issued a warning letter on (b)(4) , for among other things, manipulating analytical data, including deleting chromatograms and retesting samples into compliance. All drugs from (b)(4) remain listed on IA 66-40 at this time.

Drugs from (b)(4) , FEI (b)(4) , were listed on IA 66-40 on (b)(4) , 2 and the firm was issued a warning letter on (b)(4) , for among other things, (b)(4) . FDA determined the firm had adequately addressed the deviations on (b)(4) . 3 The firm’s drug products were removed from IA 66-40 on (b)(4) and a WLCO letter was issued on (b)(4) .

All drugs from (b)(4) , FEI (b)(4) , were listed on IA 99-32 on (b)(4) , due to the firm’s delaying and ultimately denying an inspection. All drugs from (b)(4) remain listed on IA 99-32 at this time. PCCA suppliers that received warning letters not otherwise listed above 18. (b)(4) , FEI (b)(4) , was issued a warning letter on (b)(4) , for among other things, (b)(4) . 19. (b)(4) , FEI (b)(4) , was issued a warning letter on (b)(4) , for among other things, (b)(4)…

All drugs from (b)(4) , FEI (b)(4) , were listed on IA 66-40 on (b)(4) . All drugs from (b)(4) remain listed on IA 66-40 at this time. For manufacturers whose drugs are listed on IA 66-40 for failure to conform to CGMP within the meaning of section 501(a)(2)(B), FDA has evidence that the drugs listed in the import alert appear to be adulterated. You are responsible for ensuring that the drugs you distribute are manufactured in compliance with all relevant CGMP requirements for drugs. Up to date information regarding import alerts can be found at the following FDA website: https://www.accessdata.fda.gov/cms_ia/ialist.html PCCA suppliers with drugs listed on Import Alert 99-32 for Delaying, Denying, Limiting, or Refusing an FDA Drug Inspection 9. All drugs from (b)(4) , FEI (b)(4) , were listed on IA 99-32 on (b)(4) , due to the firm’s denying FDA’s attempt to schedule a pre-announced inspection. All drugs from (b)(4) remain listed on IA 99-32 at this time.