FDA WARNING_LETTER - Continental Manufacturing Chemist, Inc. - April 28, 2017

The FDA inspected Continental Manufacturing Chemist, Inc. from April 24-28, 2017, identifying significant CGMP violations for finished pharmaceuticals, rendering their drug products adulterated. The company manufactures OTC drugs and medicated otic/oral care products, alongside non-pharmaceuticals like weed killer.

Violations include: 1. **Inadequate Segregation (21 CFR 211.42(c)):** Failure to physically separate finished drug products from lawn care and cleaning chemicals, and lack of quarantine markings for finished drug products. The company's response regarding additional space and labeling procedures was deemed insufficient, lacking detail on preventing mix-ups and separating pharmaceutical from non-pharmaceutical products. 2. **Inadequate Quality Control Unit (21 CFR 211.22(a)):** Shipping finished products before quality unit release, exemplified by multiple batches of oral rinse and fluoride toothpaste. The company's plan to discontinue this practice and revise procedures lacked sufficient detail and proof of implementation. 3. **Insufficient Investigations (21 CFR 211.192):** Failure to thoroughly investigate at least 12 out of 16 discrepancies (product quality, customer complaints) and 8 out of 16 manufacturing process discrepancies. The company's response on risk assessments and procedure revisions was inadequate, lacking details on future discrepancy closure and comprehensive investigation criteria. 4. **