Physicians Total Care, Inc. – FDA Warning Letter, Feb 24, 2012

The FDA issued a Warning Letter to Physicians Total Care, Inc. following a January-February 2012 inspection, citing significant Current Good Manufacturing Practice (CGMP) violations, rendering their drug products adulterated. Additionally, the firm was found to be repackaging and distributing unapproved new drugs and misbranded drugs.

Key violations include: 1. **Failure to test non-penicillin drugs for penicillin cross-contamination (21 CFR 211.176):** The penicillin packaging room opened to the main packaging area where other drug types were handled. The firm's response to cease penicillin packaging was inadequate as it did not include testing of existing non-penicillin products for contamination. 2. **Inadequate facility separation to prevent contamination/mix-ups (21 CFR 211.42(c), (d)):** Penicillin and cephalosporin products were packaged in the main area using shared equipment and an unseparated air handling unit. The firm's response to cease these operations was insufficient, lacking decontamination plans, environmental testing, and evaluation of impacted products. 3. **Failure to establish adequate cleaning procedures (21 CFR 211.67(b)):** Cleaning procedures lacked specifics on cleaning agent grade, frequency, and methods for various production areas and tools. The firm's updated procedures were deemed inadequate without scientific justification for the cleaning agent used. 4. **Failure to