FDA WARNING_LETTER - Homeocare Laboratories, Inc. - December 13, 2019

The FDA issued a Warning Letter to Homeocare Laboratories, Inc. following an inspection from December 2-13, 2019, identifying significant CGMP violations for finished pharmaceuticals, rendering their drug products adulterated. The firm manufactures "BIOIDENTICAL USP PROGESTERONE CREAM," an unapproved new drug. Additionally, FDA review of their website in March and May 2020 revealed other unapproved new drugs, including "Acute Asthma Relief," "Anxiety Relief," "Cholestop," "Fibromyalgia Relief," "HBP Relief," "IBS Relief," "Insomnia Relief," "Memo-Rx," "Stress Relief," and "Vigofem Plus For Women." These products are concerning due to claims for serious conditions and potential for patients to forgo effective treatments.

Key CGMP violations include: 1. **Lack of finished product testing (21 CFR 211.165(a)):** The firm released drugs without testing for identity, strength, content uniformity, or impurities. 2. **Inadequate component testing and supplier qualification (21 CFR 211.84(d)(1) & (2)):** The firm used components from unqualified suppliers without adequate testing or validating supplier COAs. 3. **Failure to validate cleaning procedures (21 CFR 211.67(a)):** Shared equipment was used for potent drugs like progesterone without validated cleaning